BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB TOUGH STRIPS

    MDR report key: 10720647 · Received October 22, 2020

    Report

    Report Number
    8041154-2020-00031
    Event Type
    Injury
    Date Received
    October 22, 2020
    Report Date
    October 9, 2020
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    381370044246
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AGE/DATE OF BIRTH, WEIGHT AND ETHNICITY/RACE WERE NOT PROVIDED FOR REPORTING. UPC:381370044246, LOT NO: 2207B, EXPIRATION DATE : N/A, UDI#: (B)(4). 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. THIS PRODUCT WAS MANUFACTURED ON AUGUST 08, 2017. (B)(4). THIS IS 4 OF 4 MED-WATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2020-00028, 8041154-2020-00029, AND 8041154-2020-00030. 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 · 1

    CONSUMER APPLIED BAB TOUGH STRIPS EXTRA LARGE 10S USA AND REPORTED EVERY TIME CONSUMER REMOVE THE BAND-AID IT ALMOST TAKES OUT THE SKIN. CONSUMER ALSO ALLEGED IT TORN PIECES OF HER SKIN, REDNESS OF THE SKIN AND IT REALLY HURTS. CONSUMER VISITED HOSPITAL FOR A TREATMENT AND HCP RECOMMENDED STOP USING IT AND PRESCRIBED ORAL ANTIBIOTICS FOR 10 DAYS. CONSUMER WAS STILL EXPERIENCING PAIN AND REDNESS. THIS IS 4 OF 4 MED-WATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2020-00028, 8041154-2020-00029, AND 8041154-2020-00030. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186395 BAB TOUGH STRIPS ADHESIVE BANDAGE KGX JOHNSON & JOHNSON CONSUMER INC 381370044246 2207B 381370044246

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention