BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB TOUGH STRIPS

    MDR report key: 10367158 · Received August 5, 2020

    Report

    Report Number
    8041154-2020-00023
    Event Type
    Injury
    Date Received
    August 5, 2020
    Date of Event
    July 7, 2020
    Report Date
    July 17, 2020
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    381370044086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE AT TIME OF EVENT, WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) BAB TOUGH STRIPS 20S USA 381370044086 8137004408USA 8137004408USA. LOT # IS NOT AVAILABLE. UDI # (B)(4). UPC = (01)381370044086. EXPIRATION DATE= NA. LOT NUMBER = NI. 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 THE LOT NUMBER. (B)(4). THIS IS 3 OF 4 MED-WATCHES BEING SUBMITTED AS SAME PATIENT WERE INVOLVED IN THIS EVENT FOR SAME PRODUCT BUT DIFFERENT LOT NUMBERS OR UNKNOWN LOT NUMBERS. SEE MEDWATCH 8041154-2020-00021; 8041154-2020-00022; 8041154-2020-00024. 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 AN EVENT WITH BAB TOUGH STRIPS. THE CONSUMER USED THE PRODUCTS ON (B)(6) 2020 FOR A CUT ON HER CHEST AND AFTER WEARING THE BANDAGES FOR SEVERAL MINUTES, HER SKIN STARTED ITCHING. SHE REMOVED THE PRODUCT IMMEDIATELY. THE NEXT DAY SHE HAD AN INFLAMED, ITCHY RASH FROM WEAR THE ADHESIVE TOUCHED HER SKIN. AFTER A FEW DAYS SHE HAD TO SEE A DERMATOLOGIST BECAUSE THE RASH WOULD GO AWAY. THE HEALTH CARE PROFESSIONAL PRESCRIBED A TRIAMCINOLONE ACETONIDE CREAM THAT HAS TO BE USED THREE TIMES. THE CONSUMER IS STILL EXPERIENCING THE SYMPTOMS OF RED RECTANGLE RASH, ITCHY, AND INFLAMED SKIN. THIS IS 3 OF 4 MED-WATCHES BEING SUBMITTED AS SAME PATIENT WERE INVOLVED IN THIS EVENT FOR SAME PRODUCT BUT DIFFERENT LOT NUMBERS OR UNKNOWN LOT NUMBERS. SEE MEDWATCH 8041154-2020-00021; 8041154-2020-00022; 8041154-2020-00024. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833703 BAB TOUGH STRIPS TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 381370044086 381370044086

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention