SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE)

Additional Manufacturer Narrative

REGARDING MASQUE LOT AG5G1D, THE SKINPEN MASQUE CONTRACT MANUFACTURER HAS REVIEWED THE RELEVANT BATCH PRODUCTION RECORDS, QUALITY CONTROL DATA, AND RELEASE INSPECTION RESULTS. BASED ON OUR INTERNAL REVIEW, NO ABNORMALITIES WERE IDENTIFIED DURING SKINPEN MASQUE MANUFACTURING OR QUALITY CONTROL FOR THIS LOT. THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

Description of Event or Problem

SEVERE SWELLING/SKIN VERY SWOLLEN/SWELLING CONTINUED TO INCREASE/LIPS APPEARED PUFFY [SWELLING FACE]. CASE NARRATIVE: UNITED KINGDOM REPORT RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA COMPANY REPRESENTATIVE ON 18-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 AN UNKNOWN INDICATION AND SKINPEN MASK/BIOCELLULOSE MASQUE (COSMETIC) TREATMENT ON THE SAME DAY. THE PATIENT'S MEDICAL HISTORY INCLUDED USE OF LA (LOCAL ANAESTHETIC) IN THE PAST FOR TATTOOS AND SEMI-PERMANENT MAKE UP. THE PATIENT WAS MEDICALLY FIT TO PROCEED. THE PATIENT HAD NO ALLERGIES AND NOT ON ANY MEDICATION. CONCOMITANT MEDICATIONS AND FOOD SUPPLEMENTS WERE NOT PROVIDED. THE MEDICAL QUESTIONNAIRE AND CONSENT WERE REVIEWED. THE SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) ONE TREATMENT SESSION WAS PERFORMED. THE ONLY PRODUCT USED ON HER SKIN PRIOR TO THE PROCEDURE WAS ZO CLEANSER AT 9 AM. PRE-PROCEDURE, SKIN WAS CLEANSED WITH MISCELLAR WATER AND CLINISEPT. LA (LOCAL ANAESTHETIC) APPLIED TO FACE AND NECK WAS REMOVED PRIOR PROCEDURE. SKIN RECLEANED WITH CLINISEPT. THE PATIENT MADE COMFORTABLE. THE EXACT SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT DEPTH AT FOREHEAD 0.5MM, AT CHEEKS 1MM, AT NOSE 0.25, AT ORBITAL RIM 0.25, AT PERIORAL 0.25, AT CHIN 0.5 AND AT NECK WAS 0.25. THE UNIFORM ERYTHEMA WAS ACHIEVED. SKINPEN GLIDE GEL WAS USED. SKINPEN MASK/BIOCELLULOSE MASQUE WAS APPLIED WITH LOT#: AG5G1D AND EXPIRATION DATE WAS 07 (INCOMPLETE DATE PROVIDED). SKIN PEN PRECISION SYSTEM AND TREATMENT KIT LOT# AND EXPIRATION DATE WERE QUERIED BUT NOT PROVIDED YET. ON (B)(6) 2026 (REPORTED AS TODAY), AFTER REMOVAL OF MASK SKIN WAS VERY SWOLLEN. THE PATIENT HAD SEVERE SWELLING, WHICH CONTINUED TO INCREASE DRAMATICALLY. THE TREATMENT FOR THE EVENT INCLUDED LORATADINE 10MG WITH LOT#: 134703 AND EXPIRATION DATE JUN-2026. THERE WAS NO INTRA ORAL SWELLING HOWEVER LIPS APPEARED PUFFY. CLIENT FELT WELL, NO RASHES, ITCHING OR SWEATING. THE PULSE WAS 59, O2 SATURATION WAS 99% AND BLOOD PRESSURE WAS 128/61. MONITORED PATIENT FOR 30 MINUTES. THERE WAS NO FURTHER INCREASE IN SWELLING HOWEVER, SHE WAS ADVISED THAT SWELLING WAS USUALLY WORSE ON DAY 2. THE PROVIDER ADVISED THE PATIENT TO GO HOME AND DRINKS LOTS OF FLUIDS, AVOID EXERCISE, HOT BATHS AND ALCOHOL. ON AN UNKNOWN DATE AFTER THE PROCEDURE, THE PATIENT ENDED UP IN A&E (ACCIDENT AND EMERGENCY) WHERE SHE RECEIVED MORE ANTIHISTAMINES AND WAS SENT HOME WITH A COURSE OF ORAL STEROIDS. THE PATIENT TEXTED THE PROVIDER THAT SHE HAD ARRIVED HOME SAFELY AND WOULD CONTINUE TO UPDATE OVERNIGHT. THE INTENSITY OF THE EVENT FACIAL SWELLING WAS SEVERE. AT THE TIME OF REPORT, THE OUTCOME OF THE EVENT FACIAL SWELLING WAS CONSIDERED AS NOT RESOLVED. IT WAS NOT REPORTED IF THE SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) PRODUCT WAS AVAILABLE FOR RETURN. HEALTH EFFECT: CLINICAL CODE: E2338, SWELLING/ EDEMA. MEDDRA PREFERRED TERM: SWELLING FACE. HEALTH EFFECT: DEVICE CODE: A0203, ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. THE PICTURES OF THE PATIENT PRE PROCEDURE AND AFTER TREATMENT WERE PROVIDED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. COMPANY COMMENT: A FEMALE PATIENT OF UNKNOWN AGE UNDERWENT TREATMENT WITH SKINPEN PRECISION SYSTEM AT FOREHEAD, CHEEKS, NOSE, ORBITAL RIM, PERIORAL AREA, CHIN AND NECK. SEVERE SWELLING WAS REPORTED AFTER SKINPEN MASQUE WAS REMOVED WHICH CONTINUED TO INCREASE. THE PATIENT WAS TREATED INITIALLY WITH LORATADINE 10 MG AND MONITORED FOR 30 MINUTES, DURING WHICH NO FURTHER PROGRESSION WAS OBSERVED. THERE WAS NO INTRAORAL SWELLING, AND VITAL SIGNS REMAINED STABLE. THE PATIENT LATER ATTENDED ACCIDENT AND EMERGENCY, WHERE SHE RECEIVED ADDITIONAL ANTIHISTAMINES AND WAS DISCHARGED WITH A COURSE OF ORAL STEROIDS. REPORTEDLY, THE PATIENT HAD NO KNOWN ALLERGIES, WAS NOT TAKING ANY CONCOMITANT MEDICATIONS, AND WAS CONSIDERED MEDICALLY FIT TO PROCEED WITH TREATMENT. CONSIDERING THE CLOSE TEMPORAL ASSOCIATION BETWEEN SKINPEN PRECISION SYSTEM ADMINISTRATION AND THE ONSET OF THE EVENT AND THE LACK OF ALTERNATIVE ETIOLOGIES IDENTIFIABLE FROM THE INFORMATION PROVIDED, THE COMPANY ASSESSED THAT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENT AND SKINPEN PRECISION SYSTEM CANNOT BE EXCLUDED AND THEREFORE CONSIDERED THE EVENTS TO BE POSSIBLY RELATED. FURTHERMORE, AS THE SWELLING OCCURRED FOLLOWING APPLICATION AND REMOVAL OF THE SKINPEN MASQUE, AND GIVEN THE TEMPORAL ASSOCIATION, A CONTRIBUTORY ROLE OF SKINPEN MASQUE IS CONSIDERED POSSIBLE. THEREFORE, THE EVENT IS ASSESSED AS POSSIBLY RELATED TO SKINPEN MASQUE. THE COMPANY WILL CONTINUE MONITORING THE BENEFIT-RISK PROFILE FOR THE PRODUCT.