SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE)

Additional Manufacturer Narrative

ON THE FOLLOW UP, TREATMENT KIT LOT CA7306 WAS IDENTIFIED. THIS TREATMENT KIT WAS KNITTED ON JOB (B)(4) ON (B)(6) 2025 FOR (B)(6). IT CONTAINED, CARTRIDGE PART F5SP021.03, LOT 25G26N, LIFT HG PART F5SP023.04 LOT 0001993229, BIOSHEATH PART F5SP022, LOT 68061836, AND RESCUE F5SF013.02 LOT N1484. A TOTAL OF (B)(4) CASES OF 12 TREATMENT KITS WERE PRODUCED UNDER LOT CA7306. THE KNITTING JOB RECORD WAS REVIEWED. THE RECORD SHOWS NO NONCONFORMING PRODUCTS AND CORRECT COMPONENTS AND QA RELEASE. THE LIFT LOT 0001993229 INCOMING INSPECTION RECORD WAS REVIEWED. THE MANUFACTURER, BIOMED PROVIDED THE LOT'S CERTIFICATE OF CONFORMITY AND CERTIFICATE OF ANALYSIS. A TOTAL OF (B)(4) TUBES OF LIFT WERE PRODUCED UNDER THIS LOT. ALL PARAMETERS PASSED AND BIOMED'S QA RELEASED THIS LOT. A SEARCH OF THE QMS DATABASE ON THE SKINFUSE LIFT HG LOT, SHOWS NO OTHER COMPLAINTS. A SEARCH OF THE DATABASE ON THE CARTRIDGE LOT, SHOWS ONE OTHER COMPLAINT, CA-(B)(4), FOR LOCKED OUT CARTRIDGE, NO PATIENT IMPACT. CARTRIDGE LOT 25G26N INCOMING INSPECTION RECORD WAS REVIEWED. A TOTAL OF (B)(4) CARTRIDGES WAS PRODUCED UNDER THIS LOT. THE COMMAND, MANUFACTURER, CERTIFICATE OF COMPLIANCE WAS RECEIVED. THE STERILIZATION RECORD FROM MIDWEST WAS RECEIVED. THE BIOLOGICAL INDICATORS SHOWED NO POSITIVE GROWTH, AND THE POSITIVE CONTROL SHOWED ONE POSITIVE GROWTH AND NO NEGATIVE GROWTH, AS EXPECTED. DURING A SKINPEN PRECISION TREATMENT, THE LIFT HG - HYDROGEL IS USED AS A GLIDE WITH THE MICRONEEDLING CARTRIDGE. ONLY THE LIFT HG AND CARTRIDGE ARE IN CONTACT WITH THE PATIENT'S SKIN. THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10

Description of Event or Problem

INFECTION/INCREASED REDNESS/MILD SWELLING/SEVERE SWELLING/BLISTER LIKE BUMPS FORMING AROUND CHIN AND MOUTH/LIKELY AN ALLERGIC REACTION/MILD-SEVERE SWELLING OF THE FACE/ITCHING/HEAT [SKIN INFECTION] SKINPEN TO TREAT DRYNESS AND DERMATITIS [OFF LABEL USE]. CASE NARRATIVE: CANADA REPORT RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA COMPANY REPRESENTATIVE ON 15-DEC-2025, REFERS TO A 29-YEARS-OLD FEMALE PATIENT WHO HAD RECEIVED A SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT ON (B)(6) 2025 FOR DRYNESS AND DERMATITIS. THE PATIENT'S MEDICAL HISTORY INCLUDED SEASONAL DERMATITIS AND COLD SORES. CONCOMITANT MEDICATIONS AND FOOD SUPPLEMENTS WERE NOT PROVIDED. THE PATIENT DID NOT HAVE ANY KNOWN ALLERGIES AT THE TIME OF TREATMENT. THE PATIENT¿S CO-SUSPECT MEDICATION INCLUDED UNSPECIFIED BIRTH CONTROL MEDICATION FOR BIRTH CONTROL INDICATION. THE SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT WAS PERFORMED AT FACE AND NECK. THE EXACT SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT DEPTH WAS 0.25-0.75 (UNITS NOT PROVIDED). THE MICRONEEDLING ENDPOINT WAS ERYTHEMA. LOT# CA7306 AND EXPIRY DATE WAS REPORTED AS: 09-MAY-2027. THE TREATMENT WAS ADMINISTERED BY SKIN CARE TECHNICIAN. SKINFUSE LIFT HG WAS USED AS PER PROTOCOL, FOLLOWED BY THE FIRST CLEANSE AT 24 HOURS USING IS CLINICAL CREAM CLEANSER AND THEN RESCUE CREAM FROM THE POST-CARE KIT. IT WAS THE FIRST TIME THE PATIENT HAD RECEIVED MICRONEEDLING TREATMENT AND THE PROVIDER DID NOT CONTINUE SERIES. ON (B)(6) 2025 (AROUND 24 HOURS POST TREATMENT), THE PATIENT EXPERIENCED INCREASED REDNESS AND MILD SWELLING. ON (B)(6) 2025, THE PATIENT EXPERIENCED MORE SEVERE SWELLING AND BLISTER-LIKE BUMPS FORMING AROUND THE CHIN AND MOUTH. ON THE SAME DAY, THE PATIENT SOUGHT VIRTUAL MEDICAL CONSULTATION AND WAS ADVISED TO MONITOR SYMPTOMS, AS THEY WERE LIKELY DUE TO AN ALLERGIC REACTION, AND TO SEEK IN-PERSON CARE IF SYMPTOMS DID NOT RESOLVE. SUBSEQUENTLY, AS SYMPTOMS PERSISTED, THE PATIENT VISITED AN URGENT CARE FACILITY, WHERE THEY RECEIVED INTRAVENOUS TREATMENT WITH UNSPECIFIED MEDICATION. THE PATIENT WAS PRESCRIBED A 7-DAY COURSE OF ANTIBIOTICS (UNSPECIFIED) FOR AN INFECTION. THE PATIENT DID NOT UNDERGO ANY LABORATORY INVESTIGATION. ON 15-DEC-2025, THE PATIENT REPORTED FEELING BETTER BUT CONTINUED TO EXPERIENCE SOME SWELLING. ON (B)(6) 2025, THE OUTCOME OF THE EVENT SKIN INFECTION WAS RESOLVED (SKIN RETURNED TO NORMAL PRETREATMENT STATE). THE INTENSITY OF THE EVENT SKIN INFECTION WAS REPORTED AS SEVERE. IT WAS UNKNOWN IF THE SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) WAS AVAILABLE FOR RETURN. THE PICTURE OF THE PATIENT WAS PROVIDED. HEALTH EFFECT: CLINICAL CODE: E1719, SKIN INFECTION MEDDRA PREFERRED TERM: SKIN INFECTION FOLLOW UP INFORMATION WAS RECEIVED HEALTH CARE PROFESSIONAL VIA COMPANY REPRESENTATIVE ON 27-DEC-2025 INCLUDED MEDICAL HISTORY (COLD SORES) ADDED, MICRONEEDLING TREATMENT (TREATMENT AREA, END POINT, TREATMENT DEPTH, TREATMENT KIT LOT NUMBER) DETAILS ADDED, EVENT 'SKIN INFECTION' OUTCOME (RESOLVED) UPDATED AND RESOLUTION DATE (19-DEC-2025) ADDED, PICTURE OF THE PATIENT WAS PROVIDED, CONFIRMATION RECEIVED THAT NO LABORATORY TESTS WERE PERFORMED. NARRATIVE WAS UPDATED ACCORDINGLY. COMPANY COMMENT: A 29-YEARS-OLD FEMALE PATIENT UNDERWENT TREATMENT WITH SKINPEN PRECISION SYSTEM AT AN UNKNOWN AREA AT AN UNSPECIFIED NEEDLE DEPTH. 24 HOURS FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED SYMPTOMS OF SKIN INFECTION AROUND CHIN AND MOUTH. IT IS TO BE NOTED THAT THE DEVICE WAS USED IN AN OFF-LABEL PROCEDURE AGAINST THE DEVICE CONTRAINDICATIONS. GIVEN THE TEMPORAL ASSOCIATION WITH THE MICRONEEDLING PROCEDURE AND THE LACK OF ALTERNATIVE ETIOLOGIES IDENTIFIABLE FROM THE INFORMATION PROVIDED, THE CAUSAL RELATIONSHIP BETWEEN THE SKIN INFECTION AND THE TREATMENT CANNOT BE EXCLUDED WITH CERTAINTY AND IS THEREFORE ASSESSED AS POSSIBLY RELATED. THE COMPANY WILL CONTINUE MONITORING THE BENEFIT-RISK PROFILE FOR THE DEVICE.

Additional Manufacturer Narrative

ON THE FOLLOW UP, TREATMENT KIT LOT CA7306 WAS IDENTIFIED. THIS TREATMENT KIT WAS KITTED ON JOB 103945 ON (B)(6) 2025 FOR RGR PHARMA, CANADIAN DISTRIBUTOR. IT CONTAINED, CARTRIDGE PART F5SP021.03, LOT 25G26N, LIFT HG PART F5SP023.04 LOT 0001993229, BIOSHEATH PART F5SP022, LOT 68061836, AND RESCUE F5SF013.02 LOT N1484. A TOTAL OF 217 CASES OF 12 TREATMENT KITS WERE PRODUCED UNDER LOT CA7306. THE KITTING JOB RECORD WAS REVIEWED. THE RECORD SHOWS NO NONCONFORMING PRODUCTS AND CORRECT COMPONENTS AND QA RELEASE. THE LIFT LOT 0001993229 INCOMING INSPECTION RECORD WAS REVIEWED. THE MANUFACTURER, BIOMED PROVIDED THE LOT'S CERTIFICATE OF CONFORMITY AND CERTIFICATE OF ANALYSIS. A TOTAL OF (B)(4) TUBES OF LIFT WERE PRODUCED UNDER THIS LOT. ALL PARAMETERS PASSED AND BIOMED'S QA RELEASED THIS LOT. A SEARCH OF THE QMS DATABASE ON THE SKINFUSE LIFT HG LOT, SHOWS NO OTHER COMPLAINTS. A SEARCH OF THE DATABASE ON THE CARTRIDGE LOT, SHOWS ONE OTHER COMPLAINT, (B)(4), FOR LOCKED OUT CARTRIDGE, NO PATIENT IMPACT. CARTRIDGE LOT 25G26N INCOMING INSPECTION RECORD WAS REVIEWED. A TOTAL OF (B)(4) CARTRIDGES WAS PRODUCED UNDER THIS LOT. THE COMMAND, MANUFACTURER, CERTIFICATE OF COMPLIANCE WAS RECEIVED. THE STERILIZATION RECORD FROM MIDWEST WAS RECEIVED. THE BIOLOGICAL INDICATORS SHOWED NO POSITIVE GROWTH, AND THE POSITIVE CONTROL SHOWED ONE POSITIVE GROWTH AND NO NEGATIVE GROWTH, AS EXPECTED. DURING A SKINPEN PRECISION TREATMENT, THE LIFT HG - HYDROGEL IS USED AS A GLIDE WITH THE MICRONEEDLING CARTRIDGE. ONLY THE LIFT HG AND CARTRIDGE ARE IN CONTACT WITH THE PATIENT'S SKIN. THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

Description of Event or Problem

INFECTION/INCREASED REDNESS/MILD SWELLING/SEVERE SWELLING/BLISTER LIKE BUMPS FORMING AROUND CHIN AND MOUTH/LIKELY AN ALLERGIC REACTION/MILD-SEVERE SWELLING OF THE FACE/ITCHING/HEAT [SKIN INFECTION]. SKINPEN TO TREAT DRYNESS AND DERMATITIS [OFF LABEL USE]. CASE NARRATIVE: CANADA REPORT RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA COMPANY REPRESENTATIVE ON (B)(6) 2025, REFERS TO A 29-YEARS-OLD FEMALE PATIENT WHO HAD RECEIVED A SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT ON (B)(6) 2025 (TO BE CONFIRMED) FOR DRYNESS AND DERMATITIS. THE PATIENT'S MEDICAL HISTORY INCLUDED SEASONAL DERMATITIS AND COLD SORES. CONCOMITANT MEDICATIONS AND FOOD SUPPLEMENTS WERE NOT PROVIDED. THE PATIENT DID NOT HAVE ANY KNOWN ALLERGIES AT THE TIME OF TREATMENT. THE PATIENT¿S CO-SUSPECT MEDICATION INCLUDED UNSPECIFIED BIRTH CONTROL MEDICATION FOR BIRTH CONTROL INDICATION. THE SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT WAS PERFORMED AT FACE AND NECK. THE EXACT SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT DEPTH WAS 0.25-0.75 (UNITS NOT PROVIDED). THE MICRONEEDLING ENDPOINT WAS ERYTHEMA. LOT# CA7306 AND EXPIRY DATE WAS REPORTED AS: 31-MAY-2027. THE TREATMENT WAS ADMINISTERED BY SKINCARE TECHNICIAN. SKINFUSE LIFT HG WAS USED AS PER PROTOCOL, FOLLOWED BY THE FIRST CLEANSE AT 24 HOURS USING IS CLINICAL CREAM CLEANSER AND THEN RESCUE CREAM FROM THE POST-CARE KIT. IT WAS THE FIRST TIME THE PATIENT HAD RECEIVED MICRONEEDLING TREATMENT AND THE PROVIDER DID NOT CONTINUE SERIES. ON (B)(6) 2025 (AROUND 24 HOURS POST TREATMENT AND (B)(6) 2025, TO BE CONFIRMED), THE PATIENT EXPERIENCED INCREASED REDNESS AND MILD SWELLING. ON (B)(6) 2025, THE PATIENT EXPERIENCED MORE SEVERE SWELLING AND BLISTER-LIKE BUMPS FORMING AROUND THE CHIN AND MOUTH. ON THE SAME DAY, THE PATIENT SOUGHT VIRTUAL MEDICAL CONSULTATION AND WAS ADVISED MONITORING SYMPTOMS, AS THEY WERE LIKELY DUE TO AN ALLERGIC REACTION, AND TO SEEK IN-PERSON CARE IF SYMPTOMS DID NOT RESOLVE. SUBSEQUENTLY, AS SYMPTOMS PERSISTED, THE PATIENT VISITED AN URGENT CARE FACILITY, WHERE THEY RECEIVED INTRAVENOUS TREATMENT WITH UNSPECIFIED MEDICATION. THE PATIENT WAS PRESCRIBED A 7-DAY COURSE OF ANTIBIOTICS (UNSPECIFIED) FOR AN INFECTION. THE PATIENT DID NOT UNDERGO ANY LABORATORY INVESTIGATION. ON (B)(6) 2025, THE PATIENT REPORTED FEELING BETTER BUT CONTINUED TO EXPERIENCE SOME SWELLING. ON (B)(6) 2025, THE OUTCOME OF THE EVENT SKIN INFECTION WAS RESOLVED (SKIN RETURNED TO NORMAL PRETREATMENT STATE). THE INTENSITY OF THE EVENT SKIN INFECTION WAS REPORTED AS SEVERE. IT WAS UNKNOWN IF THE SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) WAS AVAILABLE FOR RETURN. THE PICTURE OF THE PATIENT WAS PROVIDED. HEALTH EFFECT: CLINICAL CODE: E1719, SKIN INFECTION. MEDDRA PREFERRED TERM: SKIN INFECTION. FOLLOW UP INFORMATION WAS RECEIVED HEALTH CARE PROFESSIONAL VIA COMPANY REPRESENTATIVE ON (B)(6) 2025 INCLUDED MEDICAL HISTORY (COLD SORES) ADDED, MICRONEEDLING TREATMENT (TREATMENT AREA, END POINT, TREATMENT DEPTH, TREATMENT KIT LOT NUMBER) DETAILS ADDED, EVENT 'SKIN INFECTION' OUTCOME (RESOLVED) UPDATED AND RESOLUTION DATE ((B)(6) 2025) ADDED, PICTURE OF THE PATIENT WAS PROVIDED, CONFIRMATION RECEIVED THAT NO LABORATORY TESTS WERE PERFORMED. NARRATIVE WAS UPDATED ACCORDINGLY. FOLLOW UP INFORMATION RECEIVED FROM COMPANY REPRESENTATIVE (QUALITY ASSESSMENT DEPARTMENT) ON (B)(6) 2026, INCLUDED: PRODUCT EXPIRATION DATE UPDATED (FROM 09-MAY-2027 TO 31-MAY-2027). NARRATIVE WAS UPDATED ACCORDINGLY. COMPANY COMMENT: A 29-YEARS-OLD FEMALE PATIENT UNDERWENT TREATMENT WITH SKINPEN PRECISION SYSTEM AT AN UNKNOWN AREA AT AN UNSPECIFIED NEEDLE DEPTH. 24 HOURS FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED SYMPTOMS OF SKIN INFECTION AROUND CHIN AND MOUTH. IT IS TO BE NOTED THAT THE DEVICE WAS USED IN AN OFF-LABEL PROCEDURE AGAINST THE DEVICE CONTRAINDICATIONS. GIVEN THE TEMPORAL ASSOCIATION WITH THE MICRONEEDLING PROCEDURE AND THE LACK OF ALTERNATIVE ETIOLOGIES IDENTIFIABLE FROM THE INFORMATION PROVIDED, THE CAUSAL RELATIONSHIP BETWEEN THE SKIN INFECTION AND THE TREATMENT CANNOT BE EXCLUDED WITH CERTAINTY AND IS THEREFORE ASSESSED AS POSSIBLY RELATED. THE COMPANY WILL CONTINUE MONITORING THE BENEFIT-RISK PROFILE FOR THE DEVICE.

Description of Event or Problem

INFECTION/INCREASED REDNESS/MILD SWELLING/SEVERE SWELLING/BLISTER LIKE BUMPS FORMING AROUND CHIN AND MOUTH/LIKELY AN ALLERGIC REACTION/MILD-SEVERE SWELLING OF THE FACE/ITCHING/HEAT [SKIN INFECTION]. SKINPEN TO TREAT DRYNESS AND DERMATITIS [OFF LABEL USE]. CASE NARRATIVE: CANADA REPORT RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA COMPANY REPRESENTATIVE ON 15-DEC-2025, REFERS TO A 29-YEARS-OLD FEMALE PATIENT WHO HAD RECEIVED A SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT ON (B)(6) 2025 FOR DRYNESS AND DERMATITIS. THE PATIENT'S MEDICAL HISTORY INCLUDED SEASONAL DERMATITIS. CONCOMITANT MEDICATIONS AND FOOD SUPPLEMENTS WERE NOT PROVIDED. THE PATIENT DID NOT HAVE ANY KNOWN ALLERGIES AT THE TIME OF TREATMENT. THE PATIENT¿S CO-SUSPECT MEDICATION INCLUDED UNSPECIFIED BIRTH CONTROL MEDICATION FOR BIRTH CONTROL INDICATION. THE SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT WAS PERFORMED AT AN UNSPECIFIED AREA. THE EXACT SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT DEPTH WAS NOT REPORTED. LOT # NOT PROVIDED AND EXPIRY DATE WAS REPORTED AS: 09-MAY-2027. THE TREATMENT WAS ADMINISTERED BY SKINCARE TECHNICIAN. SKINFUSE LIFT HG WAS USED AS PER PROTOCOL, FOLLOWED BY THE FIRST CLEANSE AT 24 HOURS USING IS CLINICAL CREAM CLEANSER AND THEN RESCUE CREAM FROM THE POST-CARE KIT. IT WAS THE FIRST TIME THE PATIENT HAD RECEIVED MICRONEEDLING TREATMENT. ON (B)(6) 2025 (AROUND 24 HOURS POST TREATMENT), THE PATIENT EXPERIENCED INCREASED REDNESS AND MILD SWELLING. ON (B)(6) 2025, THE PATIENT EXPERIENCED MORE SEVERE SWELLING AND BLISTER-LIKE BUMPS FORMING AROUND THE CHIN AND MOUTH. ON THE SAME DAY, THE PATIENT SOUGHT VIRTUAL MEDICAL CONSULTATION AND WAS ADVISED TO MONITOR SYMPTOMS, AS THEY WERE LIKELY DUE TO AN ALLERGIC REACTION, AND TO SEEK IN-PERSON CARE IF SYMPTOMS DID NOT RESOLVE. SUBSEQUENTLY, AS SYMPTOMS PERSISTED, THE PATIENT VISITED AN URGENT CARE FACILITY, WHERE THEY RECEIVED INTRAVENOUS TREATMENT WITH UNSPECIFIED MEDICATION. THE PATIENT WAS PRESCRIBED A 7-DAY COURSE OF ANTIBIOTICS (UNSPECIFIED) FOR AN INFECTION. ON (B)(6) 2025, THE PATIENT REPORTED FEELING BETTER BUT CONTINUED TO EXPERIENCE SOME SWELLING. AT THE TIME OF REPORT, THE OUTCOME OF THE EVENT SKIN INFECTION WAS RESOLVING. THE INTENSITY OF THE EVENT SKIN INFECTION WAS REPORTED AS SEVERE. IT WAS UNKNOWN IF THE SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) WAS AVAILABLE FOR RETURN. HEALTH EFFECT: CLINICAL CODE: E1719, SKIN INFECTION. MEDDRA PREFERRED TERM: SKIN INFECTION. SKINPEN PRECISION SYSTEM SERIAL NUMBER AND TREATMENT KIT LOT NUMBER WERE NOT PROVIDED. THE CLINICIAN WAS CONTACTED ON MULTIPLE OCCASIONS TO REQUEST ADDITIONAL INFORMATION AS WELL AS THE DEVICE AND TREATMENT KIT TRACEABILITY INFORMATION WITH NO RESPONSE RECEIVED. COMPANY COMMENT: A 29-YEARS-OLD FEMALE PATIENT UNDERWENT TREATMENT WITH SKINPEN PRECISION SYSTEM AT AN UNKNOWN AREA AT AN UNSPECIFIED NEEDLE DEPTH. 24 HOURS FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED SYMPTOMS OF SKIN INFECTION AROUND CHIN AND MOUTH. IT IS TO BE NOTED THAT THE DEVICE WAS USED IN AN OFF-LABEL PROCEDURE AGAINST THE DEVICE CONTRAINDICATIONS. THE PATIENT¿S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS/TREATMENTS WERE NOT PROVIDED, LIMITING THE ASSESSMENT OF OTHER POTENTIAL PREDISPOSING FACTORS. GIVEN THE TEMPORAL ASSOCIATION WITH THE MICRONEEDLING PROCEDURE AND THE LACK OF ALTERNATIVE ETIOLOGIES IDENTIFIABLE FROM THE INFORMATION PROVIDED, THE CAUSAL RELATIONSHIP BETWEEN THE SKIN INFECTION AND THE TREATMENT CANNOT BE EXCLUDED WITH CERTAINTY AND IS THEREFORE ASSESSED AS POSSIBLY RELATED. THE COMPANY WILL CONTINUE MONITORING THE BENEFIT-RISK PROFILE FOR THE DEVICE.

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.