BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB TOUGH STRIPS USA BATGZTUS

    MDR report key: 15043401 · Received July 18, 2022

    Report

    Report Number
    1000599868-2022-00012
    Event Type
    Injury
    Date Received
    July 18, 2022
    Report Date
    July 20, 2022
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    381371155675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) BAB TOUGH STRIPS 1X3 1/4 IN 60S USA (B)(4), LOT NUMBER 211108. UDI #: (B)(4), UPC #:381371155675, LOT #: 211108 AND EXP: NA. 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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THIS IS 1 OF 2 MED-WATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 1000599868-2022-00013. 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.

    Additional Manufacturer Narrative · 0

    LEGAL DISCLAIMER (ALWAYS FIRST): JOHNSON & 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 & 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 & JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, JOHNSON & JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 NOVEMBER 8, 2021 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW- UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    A 76 YEAR OLD MALE CONSUMER REPORTED AN EVENT WITH BAB TOUGH STRIPS. ON (B)(6) 2022, THE CONSUMER STARTED USING THE PRODUCT TO COVER UP CUTS. WHILE REMOVING BANDAGES, HIS SKIN WAS ALSO REMOVED. HIS WIFE DROVE HIM TO A CLOSE-BY CLINIC FOR TREATMENT. CONSUMER USED TWO BANDAGES EACH TIME. THE CONSUMER VISITED A HEALTH CARE PROFESSIONAL (HCP) AND THE HCP USED A GAUZE PAD AND WRAPPED IT ON THE TORN SKIN AREA. THIS IS 1 OF 2 MED-WATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 1000599868-2022-00013. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2893381 BAB TOUGH STRIPS USA BATGZTUS TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 381371155675 211108 381371155675

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention