SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE)

Description of Event or Problem

STAPH [STAPHYLOCOCCAL SKIN INFECTION], NECK WAS RED [ERYTHEMA], NECK WAS ITCHY [PRURITUS], RASH SPREAD TO THE BACK AND CHEST [RASH]. CASE NARRATIVE: AUSTRALIA REPORT RECEIVED FROM OTHER HEALTHCARE PROFESSIONAL ON 04-FEB-2026, REFERS TO A FEMALE PATIENT OF UNKNOWN AGE WHO HAD RECEIVED A SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT ON (B)(6) 2026 FOR UNKNOWN INDICATION. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. IT WAS UNKNOWN IF PATIENT WAS ALLERGIC TO ANY DRUG OR FOOD. CONCOMITANT MEDICATIONS AND FOOD SUPPLEMENTS WERE NOT PROVIDED. THE SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT WAS PERFORMED AT UNSPECIFIED SITES. THE EXACT SKINPEN PRECISION SYSTEM TREATMENT DEPTH WAS NOT REPORTED. PRIOR TO TREATMENT, BARRIER CHECK AND PRE-PREPARATION PROGRAM WERE CONDUCTED. SKINPEN PRECISION SYSTEM TREATMENT STEPS FOLLOWED AS PER PROTOCOL AND SPOT/LESION NOTED UNDER NECK AREA (UNDER CHIN) WAS AVOIDED BY 2CM MARGIN. JUST BEFORE MICRO NEEDLING THE PATIENT WENT THROUGH NEW CELLULAR TREATMENT FACTOR (NCTF) PROCEDURE WHICH WAS OFF-LABELLED AND NOT PART OF THE SKINPEN TREATMENT PROTOCOL. AS POST-CARE, PATIENT WAS INSTRUCTED TO USE "RESCUE" (SKINFUSE RESCUE CALMING COMPLEX) THAT EVENING AND WHEN FEELING DRY FOR THE FIRST 24 HOURS AND BIOJUVE (SPECIFIC BIOJUVE PRODUCT NAMES NOT PROVIDED) AFTER 24 HOURS. PATIENT DID REPORT APPLYING SUNSCREEN AND MINERAL MAKE-UP 48 HOURS POST-TRETMENT. ON (B)(6) 2026 (REPORTED AS TWO DAYS AFTER AND ALSO ON (B)(6) 2026; TO BE CONFIRMED), THE PATIENT EXPERIENCED THAT HER NECK WAS RED, ITCHY AND ASKED FOR RECOMMENDATION TO CALM IT DOWN. THE PATIENT WAS ADVISED TO CONTINUE USING RESCUE (SKINFUSE RESCUE CALMING COMPLEX) AND TAKE ANTIHISTAMINE. ON AN UNKNOWN DATE IN 2026, THE PATIENT'S CONDITION GOT WORSE AND SHE WAS ADVISED TO SEE THE GENERAL PRACTITIONER (GP) WHO ORDERED TEST FOR STAPH. THE PATIENT WAS DIAGNOSED WITH STAPH AND ADMITTED TO THE HOSPITAL FOR UNSPECIFIED IV ANTIBIOTICS AND THE RASH SPREAD TO THE BACK AND CHEST. AT THE TIME OF REPORT, THE OUTCOME OF THE EVENT STAPHYLOCOCCAL SKIN INFECTION, RED NECK, ITCHY SKIN AND RASH ALL OVER WAS CONSIDERED AS RESOLVING. THE INTENSITY OF THE EVENTS STAPHYLOCOCCAL SKIN INFECTION, RED NECK, ITCHY SKIN AND RASH ALL OVER WAS NOT REPORTED. THE SKINPEN PRECISION SYSTEM PRODUCT WAS NOT AVAILABLE FOR RETURN. HEALTH EFFECT: CLINICAL CODE E1719, SKIN INFECTIONS. MEDDRA PREFERRED TERM: STAPHYLOCOCCAL SKIN INFECTION. HEALTH EFFECT: CLINICAL CODE E171601, ERYTHEMA. MEDDRA PREFERRED TERM: ERYTHEMA. HEALTH EFFECT: CLINICAL CODE E1708, ITCHING SENSATION. MEDDRA PREFERRED TERM: PRURITUS. HEALTH EFFECT: CLINICAL CODE E1714, RASH. MEDDRA PREFERRED TERM: RASH. HEALTH EFFECT: DEVICE CODE: A24, ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. PICTURES OF THE PATIENT WERE 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 FEMALE PATIENT OF UNKNOWN AGE WAS TREATED WITH SKINPEN PRECISION SYSTEM AT UNSPECIFIED SITES. THE PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE APPROVED TREATMENT PROTOCOL. PRIOR TO THE MICRONEEDLING PROCEDURE, THE PATIENT RECEIVED A NEW CELLULAR TREATMENT FACTOR (NCTF) PROCEDURE, WHICH IS NOT PART OF THE SKINPEN PRECISION SYSTEM TREATMENT PROTOCOL. SHORTLY AFTER THE PROCEDURE THE PATIENT EXPERIENCED ERYTHEMA, PRURITUS AND RASH. LATER, THE PATIENT WAS DIAGNOSED WITH STAPHYLOCOCCAL SKIN INFECTION AND WAS TREATED WITH IV ANTIBIOTICS. AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENTS WAS RECOVERING. THE NCTF PROCEDURE MAY HAVE BEEN A CONFOUNDING FACTOR, AS SKIN BARRIER DISRUPTION IN COMBINATION WITH AN INVASIVE PROCEDURE MAY HAVE INCREASED THE RISK OF INFECTION. CONSIDERING THE CLOSE TEMPORAL ASSOCIATION BETWEEN THE SKINPEN PRECISION SYSTEM TREATMENT AND THE ONSET OF THE REPORTED EVENTS, THE COMPANY ASSESSED THAT A CAUSAL RELATIONSHIP BETWEEN THE EVENTS AND THE SKINPEN PRECISION SYSTEM CANNOT BE EXCLUDED AND THEREFORE CONSIDERS THE EVENTS TO BE POSSIBLY RELATED. COMPLAINT TRENDS FOR PAST 2 YEARS WERE REVIEWED FOR SKINPEN PRECISION WITH NO PREVIOUS REPORTS OF STAPHYLOCOCCAL SKIN INFECTION FOLLOWING MICRONEEDLING TREATMENT. THE COMPANY WILL CONTINUE TO MONITOR THE BENEFIT¿RISK PROFILE OF THE PRODUCT.

Additional Manufacturer Narrative

COMPLAINT TRENDS FOR PAST 2 YEARS WERE REVIEWED FOR SKINPEN PRECISION WITH NO PREVIOUS REPORTS OF STAPHYLOCOCCAL SKIN INFECTION FOLLOWING MICRONEEDLING TREATMENT THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

Description of Event or Problem

STAPH [STAPHYLOCOCCAL SKIN INFECTION], NECK WAS RED [ERYTHEMA] , NECK WAS ITCHY [PRURITUS] , RASH SPREAD TO THE BACK AND CHEST [RASH] . CASE NARRATIVE: AUSTRALIA REPORT RECEIVED FROM OTHER HEALTHCARE PROFESSIONAL ON (B)(6) 2026, REFERS TO A 34-YEARS-OLD FEMALE PATIENT WHO HAD RECEIVED A SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT ON (B)(6) 2026 FOR PIGMENTATION AND UNEVEN SKIN TONE. THE PATIENT¿S PAST COSMETIC HISTORY INCLUDED 2 PREVIOUS MICRONEEDLING TREATMENTS WITHIN ONE-MONTH APART AT UNKNOWN TREATMENT SITE FOR UNKNOWN INDICATION. THE PATIENT'S MEDICAL HISTORY INCLUDED CLOSED BUMPS. THE PATIENT WAS NOT ALLERGIC TO ANY DRUG OR FOOD, HAD NO OTHER DERMATOLOGICAL HISTORY, DISEASE AFFECTING IMMUNE SYSTEM OR THYROID GLAND OR ANY FAMILY HISTORY OF AUTO-IMMUNE DISEASE. THE PATIENT WAS NOT TAKING ANY CONCOMITANT MEDICATIONS AND FOOD SUPPLEMENTS. THE SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT WAS PERFORMED AT FACE AND NECK AT DEPTH OF 0.5 MM AT FOREHEAD, UNDER EYE AND NOSE WITH 3 PASSES, 1.5 MM AT THE CHEEKS LATERAL AND MEDIAL WITH 3 PASSES, 1MM AT CHIN AND UPPER LIP WITH 3 PASSES, 1.75MM AT NECK. THE PROVIDER NOTED A SPOT/LESION UNDER THE CHIN AND AVOIDED IT BY A 2 CM MARGIN DURING TREATMENT. THE PATIENT DID NOT KNOW WHAT IT WAS, BUT THE SPOT WAS CLOSED. THIS WAS THE PATIENT¿S THIRD TREATMENT 1 MONTH APART AND PRIOR TO TREATMENT, BARRIER CHECK AND PRE-PREPARATION PROGRAM WERE CONDUCTED. SKINPEN PRECISION SYSTEM TREATMENT STEPS WERE FOLLOWED AS PER PROTOCOL. JUST BEFORE MICRO NEEDLING THE PATIENT WENT THROUGH NEW CELLULAR TREATMENT FACTOR (NCTF) BOOST 1.5 ML AS A SLIP WHICH WAS OFF-LABELLED AND NOT PART OF THE SKINPEN TREATMENT PROTOCOL. AS POST-CARE, PATIENT WAS INSTRUCTED TO USE "RESCUE" (SKINFUSE RESCUE CALMING COMPLEX) THAT EVENING AND WHEN FEELING DRY FOR THE FIRST 24 HOURS AND BIOJUVE (SPECIFIC BIOJUVE PRODUCT NAMES NOT PROVIDED) AFTER 24 HOURS, HOWEVER, THE PATIENT DID NOT START USING BIOJUVE PRODUCT. PATIENT DID REPORT APPLYING SUNSCREEN AND MINERAL MAKE-UP 48 HOURS POST-TREATMENT. ON (B)(6) 2026 (REPORTED AS 24 HOURS LATER), THE PATIENT EXPERIENCED THAT HER NECK WAS RED, ITCHY AND ASKED FOR RECOMMENDATION TO CALM IT DOWN. THE PATIENT WAS ADVISED TO CONTINUE USING RESCUE (SKINFUSE RESCUE CALMING COMPLEX) AND TAKE ANTIHISTAMINE. ON AN UNKNOWN DATE IN (B)(6) 2026, THE PATIENT'S CONDITION GOT WORSE AND SHE WAS ADVISED TO SEE THE GENERAL PRACTITIONER (GP) WHO ORDERED TEST FOR STAPH. THE PATIENT WAS DIAGNOSED WITH STAPH AND ON (B)(6) 2026, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR UNSPECIFIED IV ANTIBIOTICS THREE TIMES AND THE RASH SPREAD TO THE BACK AND CHEST. ON (B)(6) 2026, THE PATIENT WAS DISCHARGED FROM HOSPITAL. ON (B)(6) 2026, THE OUTCOME OF THE EVENTS STAPHYLOCOCCAL SKIN INFECTION, RED NECK, ITCHY SKIN AND RASH ALL OVER WAS CONSIDERED AS COMPLETELY RESOLVED. THE INTENSITY OF THE EVENTS STAPHYLOCOCCAL SKIN INFECTION, RED NECK, ITCHY SKIN AND RASH ALL OVER WAS NOT REPORTED. THE SKINPEN PRECISION SYSTEM PRODUCT WAS NOT AVAILABLE FOR RETURN. HEALTH EFFECT: CLINICAL CODE E1719, SKIN INFECTIONS MEDDRA PREFERRED TERM: STAPHYLOCOCCAL SKIN INFECTION. HEALTH EFFECT: CLINICAL CODE E171601, ERYTHEMA MEDDRA PREFERRED TERM: ERYTHEMA. HEALTH EFFECT: CLINICAL CODE E1708, ITCHING SENSATION MEDDRA PREFERRED TERM: PRURITUS. HEALTH EFFECT: CLINICAL CODE E1714, RASH MEDDRA PREFERRED TERM: RASH. HEALTH EFFECT: DEVICE CODE: A24, ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM PICTURES OF THE PATIENT WERE PROVIDED. FOLLOW UP INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE ON 18-FEB-2026 WITH ADDITIONAL INFORMATION RECEIVED FROM OTHER HEALTHCARE PROFESSIONAL ON 23-FEB-2026 INCLUDED ADDITIONAL REPORTER ADDED, PATIENT¿S AGE ADDED, COSMETIC HISTORY ADDED, MEDICAL HISTORY ADDED, SKINPEN PRECISION SYSTEM DETAILS (INDICATION FOR USE, TREATMENT AREAS, TREATMENT DEPTH, NUMBER OF PASSES) ADDED, ONSET DATE FOR EVENTS ¿NECK WAS RED AND NECK WAS ITCHY¿ (FROM 30-JAN-2026 TO 29-JAN-2026) AND EVENTS ¿STAPH¿ AND ¿RASH SPREAD TO THE BACK AND CHEST¿ (2026 TO JAN-2026) UPDATED, HOSPITALIZATION DATES ADDED AND CLINICAL INFORMATION ADDED. NARRATIVE WAS UPDATED ACCORDINGLY. COMPANY COMMENT: A 34-YEARS-OLD FEMALE PATIENT WAS TREATED WITH SKINPEN PRECISION SYSTEM AT FACE AND NECK. THE PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE APPROVED TREATMENT PROTOCOL. PRIOR TO THE MICRONEEDLING PROCEDURE, THE PATIENT RECEIVED A NEW CELLULAR TREATMENT FACTOR (NCTF) PROCEDURE, WHICH IS NOT PART OF THE SKINPEN PRECISION SYSTEM TREATMENT PROTOCOL. SHORTLY AFTER THE PROCEDURE THE PATIENT EXPERIENCED ERYTHEMA, PRURITUS AND RASH. LATER, THE PATIENT WAS DIAGNOSED WITH STAPHYLOCOCCAL SKIN INFECTION AND WAS TREATED WITH IV ANTIBIOTICS. AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENTS WAS RECOVERED. THE NCTF PROCEDURE MAY HAVE BEEN A CONFOUNDING FACTOR, AS SKIN BARRIER DISRUPTION IN COMBINATION WITH AN INVASIVE PROCEDURE MAY HAVE INCREASED THE RISK OF INFECTION. THE PATIENT REPORTED NO KNOWN DRUG OR FOOD ALLERGIES, NO PRIOR DERMATOLOGICAL HISTORY, AND NO HISTORY OF IMMUNE SYSTEM OR THYROID DISORDERS. CONSIDERING THE CLOSE TEMPORAL ASSOCIATION BETWEEN THE SKINPEN PRECISION SYSTEM TREATMENT AND THE ONSET OF THE REPORTED EVENTS, THE COMPANY ASSESSED THAT A CAUSAL RELATIONSHIP BETWEEN THE EVENTS AND THE SKINPEN PRECISION SYSTEM CANNOT BE EXCLUDED AND THEREFORE CONSIDERS THE EVENTS TO BE POSSIBLY RELATED. COMPLAINT TRENDS FOR PAST 2 YEARS WERE REVIEWED FOR SKINPEN PRECISION WITH NO PREVIOUS REPORTS OF STAPHYLOCOCCAL SKIN INFECTION FOLLOWING MICRONEEDLING TREATMENT. THE COMPANY WILL CONTINUE TO MONITOR THE BENEFIT¿RISK PROFILE OF THE PRODUCT.

Additional Manufacturer Narrative

COMPLAINT TRENDS FOR PAST 2 YEARS WERE REVIEWED FOR SKINPEN PRECISION WITH NO PREVIOUS REPORTS OF STAPHYLOCOCCAL SKIN INFECTION FOLLOWING MICRONEEDLING TREATMENT THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.