BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND BANDAGES WATERBLOCK FLEX BANDAGES

    MDR report key: 17700163 · Received September 7, 2023

    Report

    Report Number
    8041154-2023-00021
    Event Type
    Injury
    Date Received
    September 7, 2023
    Report Date
    August 15, 2023
    Manufacturer
    JOHNSON & JOHNSON INC
    Product Code
    KGX
    UDI-DI
    381371190621
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    JOHNSON & JOHNSON CONSUMER, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH JOHNSON & JOHNSON CONSUMER, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, JOHNSON & JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AND ADMISSION THAT THE DEVICE, JOHNSON & JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. B3: EVENT START DATE: (B)(6) 2023. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) BAND AID BRAND BANDAGES WATERBLOCK FLEX ADHESIVE COVER 6CT USA 381371190621, 381371190621USA, 381371190621USA, LOT NUMBER-NA. D4: UDI #: (B)(4). UPC # 381371190621. LOT NUMBER #: NI. EXPIRATION DATE: NA. D10: 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: HEALTH EFFECT CLINICAL CODE: E1714 ALSO REFERS TO CONSUMER ALLEGED ABOUT "RASHES RAN DOWN THE WOUND AREA AND RASH GOT SO BAD". E1719 ALSO REFERS TO CONSUMER ALLEGED ABOUT "SECOND-DEGREE INFECTION ON SKIN". E1707 ALSO REFERS TO CONSUMER ABOUT "WOUND GOT ENLARGED AND WORSE". THIS MEDWATCH IS FOR LOT NUMBER-NI. THREE MED WATCHES (8041154-2023-00020, 8041154-2023-00021 & 8041154-2023-00022) ARE BEING SUBMITTED AS CONSUMER REPORTED USE OF THREE DIFFERENT BOXES OF BAND-AIDS WITH THE SAME EVENT DESCRIPTION. SEE MEDWATCH 8041154-2023-00020, 8041154-2023-00021 & 8041154-2023-00022. 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 FEMALE CONSUMER REPORTED AND EVENT WITH BAND AID BRAND BANDAGES WATERBLOCK FLEX ADHESIVE COVER. CONSUMER HAD A MINOR WRIST INJURY MADE INJURY WORSE BECAUSE THERE WAS NO AIR AT ALL ONCE SHE PUT ON THE PRODUCT. SHE DEVELOPED A LOT OF RASHES THAT RAN DOWN THE WOUND AREA, AND THE WOUND GOT ENLARGED. THE RASH GOT SO BAD, IT GAVE HER A SECOND-DEGREE INFECTION. THE STICKY AREA GOT RASHES. THE SYMPTOMS HAVE REMAINED THE SAME. CONSUMER WENT TO HOSPITAL TO CLEAN UP THE WOUND AND WAS ADVISED TO IMMEDIATELY STOP USING THE BANDAGE SHE WAS DISCHARGED ON THE SAME DAY ((B)(6) 2023). THE CONSUMER WAS ALSO ADVISED BY THE DOCTOR THAT THEY USED COLLAGEN POWDER TO TREAT THE WOUND. THIS MEDWATCH IS FOR LOT NUMBER-NI. THREE MED WATCHES (8041154-2023-00020, 8041154-2023-00022) ARE BEING SUBMITTED AS CONSUMER REPORTED USE OF THREE DIFFERENT BOXES OF BAND-AIDS WITH THE SAME EVENT DESCRIPTION. SEE MEDWATCH 8041154-2023-00020, 8041154-2023-00022. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038674 BAND AID BRAND BANDAGES WATERBLOCK FLEX BANDAGES TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON INC 381371190621 381371190621

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention