BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB TOUGH STRIPS

    MDR report key: 17577173 · Received August 18, 2023

    Report

    Report Number
    8041154-2023-00016
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    July 22, 2023
    Report Date
    July 26, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    381370044086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    JOHNSON & AMP; 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 & AMP; 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 & AMP; JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AND ADMISSION THAT THE DEVICE, JOHNSON & AMP; JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A2, A4, A5: PATIENT AGE AT TIME OF EVENT, WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) BAB TOUGH STRIPS 20S USA 381370044086, 8137004408USA 8137004408USA, LOT NUMBER: 2702B. D4: UDI#: (B)(4). UPC# (B)(4). LOT NUMBER#: 2702B. EXPIRATION DATE: NA. D10: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW / INVESTIGATION. H3, H4, H6: 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 SEPTEMBER 27, 2022. H6: HEALTH EFFECT CLINICAL CODE: E1721 ALSO REFERS TO CONSUMER ALLEGED ABOUT & QUOT; PULLS SKIN, PULL THE WOUND OPEN, LEAVES SKIN VERY SORE, DEEP WOUND, VERY PAINFUL TO REMOVE, BLEEDING & QUOT;. E2402 REFERS TO CONSUMER & QUOT; INTENTIONAL MISUSE / OFF-LABEL USE" OF THE PRODUCT. THIS IS THREE OF FIVE MEDWATCHES BEING SUBMITTED AS FIVE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH NUMBERS 8041154-2023-00014, 8041154-2023-00015, 8041154-2023-00017 & AMP; 8041154-2023-00018. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 0

    A FEMALE CONSUMER REPORTED AN EVENT WITH BAND AIDE TOUGH STRIPS. THE CONSUMER USED THE TOUGH STRIP BANDAGES TO COVER A WOUND. THE CONSUMER APPLIED ¿BACITRACIN¿ ON THE WOUND AND THEN APPLIED THE BANDAGES. CONSUMER ALLEGES THAT THE STICKY PART WAS VERY STRONG. IT PULLED HER SKIN OFF, WAS PAINFUL TO REMOVE, AND WAS VERY DIFFICULT TO OPEN AS THERE WAS NO TAB. IT WAS REPORTED THAT CONSUMER USED TOTAL OF 5 BANDAGES. THE CONSUMER ALLEGES THE ADHESIVE WAS TOO STRONG AND IT CAUSED SKIN REMOVAL, SORENESS, PULLED THE WOUND OPEN AND BLEEDING. UPON THE BLEEDING, SHE CALLED HER DOCTOR TO GET A TETANUS SHOT AS THE WOUND WAS DEEP. THE CONSUMER IS STILL EXPERIENCING THE SYMPTOMS WHILE REPORTING THIS EVENT. THIS IS THREE OF FIVE MEDWATCHES BEING SUBMITTED AS FIVE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH NUMBERS 8041154-2023-00014, 8041154-2023-00015, 8041154-2023-00017 & AMP; 8041154-2023-00018. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2173056 BAB TOUGH STRIPS TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 381370044086 2702B 381370044086

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention