SKINPEN PRECISION ELITE SYSTEM (POWERED MICRONEEDLE DEVICE)

Description of Event or Problem

INFECTION/SOME SORT OF INFECTION/WHITE/YELLOW PUSS COMING FROM THE CHEEKS/VERY RED AND INFLAMED/DIVETS IN SKIN FROM TREATMENT/ STILL VEY SWOLLEN [SKIN INFECTION] CASE NARRATIVE: UNITED STATES REPORT RECEIVED FROM A PHYSICIAN VIA COMPANY REPRESENTATIVE ON (B)(6) 2025 REFERS TO A NOT HISPANIC OR LATINO FEMALE PATIENT WHO HAD RECEIVED A SKINPEN PRECISION ELITE SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT COMBINED WITH UNSPECIFIED STEAM CELLS ON (B)(6) 2025. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT MEDICATIONS AND FOOD SUPPLEMENTS WERE NOT PROVIDED. THE SKINPEN PRECISION ELITE SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT IN COMBINATION WITH UNSPECIFIED STEM CELLS WAS PERFORMED ON THE FACE AREA. THE EXACT SKINPEN PRECISION ELITE SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT DEPTH WAS NOT REPORTED. LOT # AND EXPIRATION DATE WAS NOT PROVIDED. ON (B)(6) 2025 (ALSO REPORTED AS FOUR DAYS POST-TREATMENT), THE PATIENT EXPERIENCED ''SOME SORT OF INFECTION'', WITH WHITE OR YELLOW PUS COMING FROM THE CHEEKS. WHEN THE PATIENT WIPED THE AREA WITH A CLEANSING WIPE, A BIT OF YELLOW DISCHARGE WAS VISIBLE. THE PATIENT COULD SEE THE SURFACE OF THE INFECTION COMING OUT WHEN LOOKING IN A CLOSE-UP MIRROR. THERE WERE SIGNIFICANT REDNESS AND INFLAMMATION. THE PATIENT WAS PRESCRIBED MEDICATION AND STEROID TO MANAGE THE INFECTION. SUBSEQUENTLY, A LASER TREATMENT WAS ADMINISTERED TO HELP REPAIR THE DAMAGE. THE PATIENT DID NOT HAVE A FEVER, AND THE AREA WAS NOT PAINFUL TO TOUCH. THE PATIENT RECEIVED ONE SESSION OF LASER TREATMENT AS PART OF THE MANAGEMENT PLAN. THE PATIENT DID NOT UNDERGO ANY LABORATORY OR DIAGNOSTIC TESTS. THE PATIENT HAD DIVETS IN SKIN FROM TREATMENT OR INFECTION. THE EVENT SKIN INFECTION WAS ALLEGED TO HAVE CAUSED DISABILITY. AT THE TIME OF REPORT, OUTCOME OF THE EVENT SKIN INFECTION WAS CONSIDERED AS RESOLVING. THE INTENSITY OF THE EVENT SKIN INFECTION WAS NOT REPORTED. THE SKINPEN PRECISION ELITE SYSTEM (POWERED MICRONEEDLE DEVICE) PRODUCT WAS NOT AVAILABLE FOR RETURN. PICTURE OF THE PATIENT WAS PROVIDED. HEALTH EFFECT: CLINICAL CODE: E1719, FDA CODE: 4544 SKIN INFECTION. MEDDRA PREFERRED TERM: SKIN INFECTION. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. 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. AS DEVICE TRACEABILITY INFORMATION WAS NOT PROVIDED, APPLICABLE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. CUSTOMER COMPLAINTS WERE REVIEWED WITH NO PREVIOUS EVENTS OF INFECTION FOLLOWING TREATMENT OF SKINPEN PRECISION ELITE USING UNSPECIFIED STEM CELLS REPORTED. THERE ARE NO ON-GOING TRENDS OF THIS NATURE. COMPANY COMMENT: A FEMALE PATIENT OF UNKNOWN AGE UNDERWENT TREATMENT WITH SKINPEN PRECISION ELITE SYSTEM COMBINED WITH UNSPECIFIED STEM CELLS ON THE FACE AREA AT AN UNSPECIFIED NEEDLE DEPTH. FOUR DAYS FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED A SKIN INFECTION ON THE CHEEKS. THE USE OF STEM CELLS IN CONJUNCTION WITH SKINPEN MICRONEEDLING IS NOT IN ACCORDANCE WITH THE APPROVED AUTHORIZED SKINPEN PRECISION ELITE INSTRUCTIONS FOR USE. THE UNSPECIFIED STEM CELL THERAPY MENTIONED IN THIS EVENT WAS USED IN AN OFF-LABEL AESTHETIC PROCEDURE UNDER THE PROVIDER'S DISCRETION AND THE PATIENT PREFERENCE. GIVEN THE BIOLOGICAL ACTIVITY AND KNOWN INFLAMMATORY POTENTIAL OF STEM-CELL-BASED PRODUCTS, THEIR CONTRIBUTION TO THE REPORTED EVENTS CANNOT BE EXCLUDED. AT THE SAME TIME, SKINPEN-RELATED CONTRIBUTION ALSO CANNOT BE DEFINITIVELY RULED OUT, THEREFORE THE RELATIONSHIP IS ASSESSED AS POSSIBLY RELATED PENDING ADDITIONAL DETAILS ON THE STEM-CELL PREPARATION AND OTHER PROCEDURAL FACTORS.

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.