BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX

    MDR report key: 24747205 · Received March 31, 2026

    Report

    Report Number
    8041154-2026-00005
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    March 10, 2026
    Report Date
    March 31, 2026
    Manufacturer
    KENVUE BRANDS, LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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, AND 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 381371183494USA, LOT NUMBER 3213B. D4: 510(K) EXEMPT DEVICE I COMPLAINT. UDI NOT REQUIRED. UDI: (01)381371183494(10)3213B UPC = 381371183494 EXPIRATION DATE= NA LOT NUMBER = 3213B D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION AND PRODUCT WAS MANUFACTURED PER SPECIFICATION. THE PRODUCT WAS MANUFACTURED ON NOVEMBER 17, 2023. H6: E2402 REFERS TO CONSUMER ALLERGIC REACTION - RASH ON SKIN, VERY ITCHY USING THE PRODUCT. CONSUMER REPORTED AFTER USING BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION FOR A CUT ON A THIGH DEVELOPED A RASH AND A PRESCRIBED CREAM WAS USED TO REDUCE THE RASH. NO REPORT OF HOSPITALIZATION OR ANY SIGNIFICANT MEDICAL TREATMENT OR INTERVENTION. BASED ON THE REVIEW OF THE INFORMATION ABOUT THE EVENT THERE WAS NO HOSPITALIZATION, NO SIGNIFICANT INTERVENTION REPORTED AND NO OTHER SERIOUS CRITERIA MET. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES 8041154-2026-00005, 8041154-2026-00006 & 8041154-2026-00007. THE SAME PATIENT 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 66-YEAR-OLD FEMALE CONSUMER REPORTED DEVELOPING A RASH AFTER APPLYING BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION BAND-AID TO A CUT ON HER THIGH. CONSUMER ALLEGED A BIG RASH ON SKIN AND VERY ITCHY. SHE INDICATED A POSSIBLE ALLERGY TO PRODUCT. CONSUMER STATED SHE USED A CREAM PRESCRIBED BY HER DOCTOR TO REDUCE THE RASH. IT WAS REPORTED THAT, CONSUMER USED THREE BAND-AIDS IN A DAY. THE CONSUMER SYMPTOMS IMPROVED AFTER THE PATIENT STOPPED USING THE PRODUCT. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES 8041154-2026-00005, 8041154-2026-00006 & 8041154-2026-00007. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809904 BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX TAPE AND BANDAGE, ADHESIVE KGX KENVUE BRANDS, LLC 381371183494 3213B

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention