BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND HYDROSEAL BANDAGES EXTRA LARGE

    MDR report key: 21332497 · Received February 7, 2025

    Report

    Report Number
    2214133-2025-00004
    Event Type
    Injury
    Date Received
    February 7, 2025
    Date of Event
    January 27, 2025
    Report Date
    February 7, 2025
    Manufacturer
    KENVUE BRANDS, LLC
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. A5, A5: PATIENT WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) BAND AID BRAND HYDROSEAL BANDAGES EXTRA LARGE 3CT USA 381371174003 8137117400USA, LOT NUMBER NI. D4: 510(K) EXEMPT DEVICE I COMPLAINT. UPC 381371174003, LOT NUMBER: NI, EXPIRATION DATE: NA. D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. H6: E1704 REFERS TO THE CONSUMER ALLEGED BURNS; E2402 REFERS TO THE CONSUMER MISUSED THE PRODUCT TO COVER ¿BITE¿ WOUND. 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 MOTHER REPORTED HER 22-YEAR-OLD DAUGHTER USED ONE EXTRA LARGE BAND AID BRAND HYDROSEAL BANDAGE FOR A ¿BITE¿ WOUND ON (B)(6) 2026, THE NEXT DAY ON (B)(6) 2025 HER DAUGHTER¿S ¿SKIN GOT BURNS¿. THE CONSUMER STATED THAT THE DAUGHTER SOUGHT MEDICAL ATTENTION AND VISITED HER HEATH CARE PROFESSIONAL (HCP). HCP PRESCRIBED UNSPECIFIED STEROIDS FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248239 BAND AID BRAND HYDROSEAL BANDAGES EXTRA LARGE DRESSING, WOUND, OCCLUSIVE NAD KENVUE BRANDS, LLC 381371174003

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Required Intervention