MICROPEN EVO MICRONEEDLING DEVICE

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

Description of Event or Problem

LESS FIRMNESS (MY FACE LOOKED DEFLATED AND LESS PLUMP AROUND THE UPPER CHEEKS) [SKIN LAXITY]. EXTREME DRYNESS [APPLICATION SITE DRYNESS]. ITCHINESS [APPLICATION SITE PRURITUS]. TEXTURE CHANGES [SKIN TEXTURE ABNORMAL]. TINY PINHOLE MARKS ABOVE MY EYEBROWS AND ON MY NOSE, SMALL NICKS RESEMBLING TRACK MARKS ON MY CHEEKS, AND DEEP VERTICAL LINES ON THE SIDES OF MY FACE [APPLICATION SITE SCAR]. MICROPEN EVO FOR POST-INFLAMMATORY HYPERPIGMENTATION [OFF LABEL USE]. CASE NARRATIVE: CANADA REPORT RECEIVED FROM A CONSUMER VIA COMPANY REPRESENTATIVE ON 22-DEC-2025, REFERS TO A FEMALE PATIENT OF AN UNKNOWN AGE WHO HAD RECEIVED A MICROPEN EVO MICRONEEDLING DEVICE (POWERED MICRONEEDLE DEVICE) TREATMENT ON (B)(6) 2024 FOR POST-INFLAMMATORY HYPERPIGMENTATION. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT MEDICATIONS, AND FOOD SUPPLEMENTS WERE NOT PROVIDED. MICROPEN EVO MICRONEEDLING DEVICE (POWERED MICRONEEDLE DEVICE) TREATMENT WAS PERFORMED ON AN ENTIRE FACE. THE EXACT MICROPEN EVO MICRONEEDLING DEVICE (POWERED MICRONEEDLE DEVICE) TREATMENT DEPTH WAS NOT REPORTED. ON AN UNKNOWN DATE IN 2024, (REPORTED AS A FEW DAYS POST TREATMENT, TO BE CONFIRMED) AFTER USING ONLY THE HYALURONIC ACID SERUM PROVIDED BY HER AESTHETICIAN, ALONG WITH A GENTLE CLEANSER, MOISTURIZER, AND SUNSCREEN, THE PATIENT NOTICED CHANGES (NOT SPECIFIED) IN HER SKIN AND INITIALLY BELIEVED THESE CHANGES WERE PART OF THE NATURAL HEALING PROCESS, AS THE AESTHETICIAN HAD EXPLAINED THAT MICRONEEDLING CAUSES CONTROLLED MICRO-INJURIES TO THE SKIN. ON (B)(6) 2025, AFTER GIVING AMPLE TIME FOR HEALING, THE PATIENT REACHED OUT TO HER AESTHETICIAN BY TEXT TO EXPRESS HER CONCERNS. ON (B)(6) 2025, THE PATIENT FOLLOWED UP AGAIN. THE CHANGES IN THE PATIENT¿S SKIN WERE QUITE NOTICEABLE, INCLUDING LESS FIRMNESS WITH THE FACE APPEARING DEFLATED AND LESS PLUMP AROUND THE UPPER CHEEKS, EXTREME DRYNESS AND ITCHINESS, TEXTURE CHANGES, TINY PINHOLE MARKS ABOVE THE EYEBROWS AND ON THE NOSE, SMALL NICKS RESEMBLING TRACK MARKS ON THE CHEEKS, AND DEEP VERTICAL LINES ON THE SIDES OF THE FACE. AT THE TIME OF REPORT, THE OUTCOME OF THE EVENTS SKIN LAXITY, APPLICATION SITE DRYNESS, APPLICATION SITE ITCHING, SKIN TEXTURE ABNORMAL, APPLICATION SITE SCAR WAS CONSIDERED AS NOT RESOLVED. THE INTENSITY OF THE EVENTS SKIN LAXITY, APPLICATION SITE DRYNESS, APPLICATION SITE ITCHING, SKIN TEXTURE ABNORMAL, APPLICATION SITE SCAR WAS NOT REPORTED. IT WAS NOT REPORTED IF THE MICROPEN EVO MICRONEEDLING DEVICE (POWERED MICRONEEDLE DEVICE) PRODUCT WAS AVAILABLE FOR RETURN. THE PICTURES OF PATIENT BEFORE AND AFTER TREATMENT WERE PROVIDED. MICROPEN EVO SERIAL NUMBER AND TREATMENT KIT LOT NUMBER WERE NOT PROVIDED. THE PATIENT-REPORTER CONFIRMED THAT SHE DID NOT WANT TO PROVIDE ANY INFORMATION ON THE AESTHETICIAN WHO HAD TREATED HER. THEREFORE, THE TREATING PROVIDER CAN NOT BE CONTACTED FOR ADDITIONAL DETAILS. THE REPORTED EVENT INDICATES THAT THE TREATMENT WAS PERFORMED FOR POST-INFLAMMATORY HYPERPIGMENTATION. THIS IS OUTSIDE THE SCOPE OF THE DEVICE INDICATIONS FOR USE. THE MICROPEN EVO IS A MICRONEEDLING DEVICE AND ACCESSORIES INTENDED TO BE USED AS A TREATMENT TO IMPROVE THE APPEARANCE OF WRINKLES OF THE NECK FOR FITZPATRICK SKIN TYPES II - IV AND TO IMPROVE THE APPEARANCE OF FACIAL ACNE SCARS IN ADULTS WITH ALL FITZPATRICK SKIN TYPES AGED 22 YEARS AND OLDER. HEALTH EFFECT: CLINICAL CODE: E1717, SKIN DISORDERS. MEDDRA PREFERRED TERM: SKIN LAXITY. HEALTH EFFECT: CLINICAL CODE: E1724, DRY SKIN. MEDDRA PREFERRED TERM: APPLICATION SITE DRYNESS. HEALTH EFFECT: CLINICAL CODE: E1708, ITCHING SENSATION. MEDDRA PREFERRED TERM: APPLICATION SITE PRURITUS. HEALTH EFFECT: CLINICAL CODE: E1717, SKIN DISORDERS. MEDDRA PREFERRED TERM: SKIN TEXTURE ABNORMAL. HEALTH EFFECT: CLINICAL CODE: E1715, SCAR TISSUE. MEDDRA PREFERRED TERM: APPLICATION SITE SCAR. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. COMPANY COMMENT: A FEMALE PATIENT OF UNKNOWN AGE UNDERWENT TREATMENT WITH MICROPEN EVO MICRONEEDLING DEVICE AT AN UNSPECIFIED DEPTH FOR POST-INFLAMMATORY HYPERPIGMENTATION. SHORTLY AFTER THE PROCEDURE, THE PATIENT NOTICED CHANGES IN HER SKIN, INCLUDING DECREASED FIRMNESS, EXTREME DRYNESS, ITCHINESS, AND TEXTURE CHANGES, WHICH PERSISTED FOR MORE THAN ONE YEAR FOLLOWING THE TREATMENT. GIVEN THAT THE EVENTS WERE REPORTED TO HAVE LASTED FOR OVER A YEAR POST-PROCEDURE, WHICH EXCEEDS THE EXPECTED HEALING TIMEFRAME, THESE EVENTS WERE ASSESSED AS PERSISTENT AND THE MDR ASSESSED AS REPORTABLE. THE PATIENT¿S MEDICAL HISTORY WAS 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 PROVIDED INFORMATION, THE CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENTS 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.