BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB TOUGH STRIPS

    MDR report key: 9251013 · Received October 29, 2019

    Report

    Report Number
    8041154-2019-00084
    Event Type
    Injury
    Date Received
    October 29, 2019
    Report Date
    October 3, 2019
    Manufacturer
    JOHNSON AND JOHNSON CONSUMER INC.
    Product Code
    KGX
    UDI-DI
    381371155675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. : PATIENT ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. (B)(4). LOT NUMBER = 3458B; EXPIRATION DATE= NA. 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. THE PRODUCT WAS MANUFACTURED ON DECEMBER 11, 2018. (B)(4). THIS IS 1 OF 4 MED-WATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2019-00084, 8041154-2019-00085, 8041154-2019-00086, 8041154-2019-00087. 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

    A FEMALE CONSUMER REPORTED THAT AFTER USED FOUR BAB TOUGH STRIPS TO COVER A WOUND OVERNIGHT, THE BANDAGES PULLED HER SKIN OFF WHEN THEY WERE REMOVED. THE CONSUMER SOUGHT MEDICAL ATTENTION AND THE DOCTOR TREATED THE WOUND AND APPLIED A BUTTERFLY BANDAGE & DRESSING. THE CONSUMER WOULD RETURN IN TWO WEEKS TO CHANGE THE DRESSING. THE WOUND WAS RED, RAW AND STILL BLEEDING AT THE TIME OF THE REPORTING. THIS IS 1 OF 4 MED-WATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2019-00084, 8041154-2019-00085, 8041154-2019-00086, 8041154-2019-00087. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046598 BAB TOUGH STRIPS ADHESIVE BANDAGE KGX JOHNSON AND JOHNSON CONSUMER INC. 381371155675 3458B 381371155675

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention