BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX

    MDR report key: 23066527 · Received September 16, 2025

    Report

    Report Number
    8041154-2025-00011
    Event Type
    Injury
    Date Received
    September 16, 2025
    Report Date
    September 16, 2025
    Manufacturer
    KENVUE BRANDS, LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 AND 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: WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4; THIS REPORT IS FOR (1)BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX LARGE ADHESIVE COVER 6CT USA 381371192526 381371192526USA 381371192526USA, LOT # 0985B D4: 510(K) EXEMPT, DEVICE I COMPLAINT. UDI NOT REQUIRED. UDI #(B)(4). UPC #381371192526 LOT #0985B EXPIRATION DATE: NA D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H4, H6: 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 APRIL 8, 2025. VISUAL INSPECTION WAS PERFORMED ON THE RETAIN SAMPLES AND ALL RESULTS MET SPECIFICATION. H6: E1719 ALSO REFERS TO THE CONSUMER ALLEGED LEG BECAME INFECTED E2330 ALSO REFERS TO THE CONSUMER ALLEGED CAUSED GREAT PAIN E2402 REFERS TO CONSUMER "INTENTIONAL MISUSE/OFF-LABEL USE" OF THE PRODUCT. BASED ON OVERALL DETAILS AVAILABLE, EVENTS INTERPRETED AS APPLICATION SITE SKIN INFECTION AND APPLICATION SITE PAIN, NO DIRECT REPORT OF ANY HCP DIAGNOSIS IN AVAILABLE INFORMATION. CONSUMER HAD TO TAKE ¿CEPHALAXEN¿ AND ¿MELOXICAM¿ (ROUTE FOR BOTH INTERPRETED AS ORAL) AND RUBBED ¿LIDOCAINE CREAM¿ TO TREAT THE EVENTS; HCP WAS ALSO CONSULTED WHO PRESCRIBED TRAMADOL (ROUTE INTERPRETED AS ORAL). BASED ON THE REVIEW OF THE EVENT INFORMATION PROVIDED, THE LIKELIHOOD THAT THE COMPLAINT CAUSING OR CONTRIBUTING TO A SERIOUS INJURY OR DEATH IF THE ISSUE WERE TO RECUR IS REMOTE. NO HOSPITALIZATION, NO SIGNIFICANT INTERVENTION REPORTED AND NO OTHER SERIOUSNESS CRITERIA MET SO CASE ASSESSED AS NON-SERIOUS, SEVERITY MINOR, CAUSALITY NOT RELATED FOR APPLICATION SITE SKIN INFECTION. THREE MEDWATCHES (8041154-2025-00009, 8041154-2025-00010. ARE BEING SUBMITTED AS THREE DEVICES WERE INVOLVED WITH THE SAME EVENT DESCRIPTION. SEE MEDWATCH 8041154-2025-00009, 8041154-2025-00010 & 8041154-2025-00011. 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 64-YEAR-OLD MALE CONSUMER REPORTED USING BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX ADHESIVE BANDAGE WHEREBY THE WHITE BANDAGE MATERIAL IS OFF CENTER AND IMPROPERLY POSITIONED ON THE BANDAGE. CONSUMER REPORTED DUE TO LACK OF ADHESIVE, HE WORE 3-4 OF THESE A DAY, SOMETIMES HAVING TO OVERLAP THEM, BUT WITH NO SUCCESS. CONSUMER ALLEGED THAT HIS LEG GOT INFECTED AND CAUSED HIM GREAT PAIN. CONSUMER REPORTED THE DOCTOR TREATED HIM WITH CEPHALEXIN, RUBBED LIDOCAINE CREAM ON UNBANDAGED SKIN, MELOXICAM FOR PAIN AND TRAMADOL SO THE CONSUMER COULD SLEEP. NO FURTHER INFORMATION FROM CONSUMER. THREE MEDWATCHES (8041154-2025-00009, 8041154-2025-00010) ARE BEING SUBMITTED AS THREE DEVICES WERE INVOLVED WITH THE SAME EVENT DESCRIPTION. SEE MEDWATCH 8041154-2025-00009, 8041154-2025-00010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2680111 BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX TAPE AND BANDAGE, ADHESIVE KGX KENVUE BRANDS, LLC 381371192526 0985B

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention