BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX

    MDR report key: 23850422 · Received December 19, 2025

    Report

    Report Number
    8041154-2025-00017
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 19, 2025
    Manufacturer
    KENVUE BRANDS, LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    KENVUE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH KENVUE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, KENVUE OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, KENVUE, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IN AUGUST 2023 JOHNSON & JOHNSON¿S CONSUMER HEALTH BUSINESS SEPARATED FROM JOHNSON & JOHNSON, AND WE BECAME AN INDEPENDENT PUBLIC COMPANY, KENVUE. AS PART OF OUR ONGOING EVOLUTION, KENVUE UPDATED THE NAME OF ITS US OPERATING COMPANY, JOHNSON & JOHNSON CONSUMER INC. (¿JJCI¿) TO ¿KENVUE BRANDS LLC¿ ON OCTOBER 28, 2024. KENVUE RECENTLY MOVED TO ITS NEW CORPORATE HEADQUARTERS IN SUMMIT NJ. ITS PREVIOUS CORPORATE HEADQUARTERS WAS 199 GRANDVIEW ROAD, SKILLMAN, NJ 08558. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A4, A5, A6: PATIENT WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4; THIS REPORT IS FOR ONE (1) BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX EXTRA LARGE 7CT USA 381371183494 381371183494USA, LOT #1065B D4: 510(K) EXEMPT, DEVICE I COMPLAINT. UDI NOT REQUIRED. UDI # (01)381371183494(10)1065B UPC # 381371183494 LOT # 1065B EXPIRATION DATE: NA D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H4, H6: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED. THERE WERE NO PROCESSING OR PACKAGING DEVIATIONS ASSOCIATED WITH THIS BATCH. RAW MATERIAL AND COMPONENT RECORDS WERE REVIEWED FOR THIS LOT. ALL RAW MATERIALS PASSED THE INCOMING QUALITY INSPECTION WITH NO ISSUES SEEN. THERE WERE NO CHANGES TO ANY RAW MATERIALS USED FOR THIS LOT. ALL COMPONENTS ALSO PASSED THE INCOMING QUALITY INSPECTION WITH NO ISSUES SEEN. THE PRODUCT WAS MANUFACTURED ON APR 16, 2025. H6: E172006 - REFERS TO THE CONSUMER ALLEGED " BREAK OUT IN HIVES" E1721 - REFERS TO THE CONSUMER ALLEGED " PRODUCT RIPPED OFF SKIN" E1715 - REFERS TO THE CONSUMER ALLEGED " PRODUCT CAUSED SCARRING¿. E2402 - REFERS TO THE CONSUMER MISUSED THE PRODUCT TO HOLD FENTANYL PATCH IN PLACE. THE CONSUMER USED THE PRODUCT TO HOLD ¿FENTANYL PATCH¿ IN PLACE (INTERPRETED AS MISUSE) AND REPORTED BREAKING OUT IN HIVES (SUBSUMED IRRITATION) AND THAT THE PRODUCT ¿RIPPED OFF SKIN¿ WHEN REMOVING IT (EVENT INTERPRETED AS SKIN TEAR, SUBSUMED PAIN). IT WAS ALSO REPORTED THAT THE PRODUCT CAUSED ¿SCARRING ALL OVER BODY¿; BASED ON OVERALL DETAILS AVAILABLE SCARRING WAS INTERPRETED TO BE AT THE SITE OF APPLICATION. MEDICAL HISTORY NOTED, NO REPORT OF ANY WORSENING OF PRE-EXISTING CONDITION ATTRIBUTED TO PRODUCT USAGE. CONSUMER WENT TO A DERMATOLOGIST AND WAS TREATED WITH ¿MOMETASONE FUROATE TOPICAL SOLUTION¿. THERE WAS NO HOSPITALIZATION, NO SIGNIFICANT INTERVENTION REPORTED AND NO OTHER SERIOUSNESS CRITERIA MET. THIS IS TWO OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2025-00016 FOR FIRST PRODUCT & MEDWATCH 8041154-2025-00017 FOR SECOND PRODUCT. THE SAME PATIENT AND EVENT IS REPRESENTED IN EACH MEDWATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    A 62-YEAR-OLD FEMALE CONSUMER STARTED TO USE BAND AID BRAND BANDAGE WATERBLOCK FLEX ADHESIVE COVER AND BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX EXTRA LARGE ON (B)(6) 2025 TO HOLD A FENTANYL PATCH IN PLACE. THE CONSUMER REPORTED BREAKING OUT IN HIVES ON (B)(6) 2025, THAT THE PRODUCT RIPPED OFF SKIN WHEN REMOVING IT, CAUSED SCARRING ALL OVER BODY. THE CONSUMER REPORTED THAT THE SYMPTOMS IMPROVED AFTER SHE STOPPED USING THE PRODUCT. CONSUMER WENT TO A DERMATOLOGIST AND WAS TREATED WITH MOMETASONE FUROATE TOPICAL SOLUTION. THIS IS TWO OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2025-00016 FOR FIRST PRODUCT & MEDWATCH 8041154-2025-00017 FOR SECOND PRODUCT. THE SAME PATIENT AND EVENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256972 BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX TAPE AND BANDAGE, ADHESIVE KGX KENVUE BRANDS, LLC 381371183494 1065B

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention