BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND-AID UNSPECIFIED USA BABGENUS

    MDR report key: 12380101 · Received August 27, 2021

    Report

    Report Number
    8041154-2021-00029
    Event Type
    Injury
    Date Received
    August 27, 2021
    Report Date
    August 18, 2021
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT BIRTH YEAR WAS REPORTED AS 1958. THIS REPORT IS FOR UNKNOWN BAND AID BANDAGE. UPC#, LOT# AND UDI # IS NOT AVAILABLE DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. SEE MEDWATCHES 8041154-2021-00026, 8041154-2021-00027, 8041154-2021-00028. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCHES. 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 · 1

    IT WAS REPORTED THAT WIFE¿S HUSBAND EXPERIENCED ANAPHYLAXIS FROM PAST USE OF BAND-AID UNSPECIFIED USA BABGENUS. THE CONSUMER WENT TO THE EMERGENCY ROOM. THERE ARE NO DETAILS REGARDING TREATMENT OF EVENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SEE MEDWATCHES 8041154-2021-00026, 8041154-2021-00027, 8041154-2021-00028. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276404 BAND-AID UNSPECIFIED USA BABGENUS TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L