BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB FLEXIBLE FABRIC BANDAGES

    MDR report key: 17798339 · Received September 22, 2023

    Report

    Report Number
    1000599868-2023-00012
    Event Type
    Injury
    Date Received
    September 22, 2023
    Report Date
    August 30, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 AND 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. A4, A5: PATIENT WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) BAB FLEXIBLE FABRIC ASSORTED 100 CT USA 381371150786 8137115078USA 8137115078USA, LOT NUMBER 220312. D4: UDI #: (B)(4). UPC # 381371150786. EXPIRATION DATE: NA. LOT NUMBER #: 220312. 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 MARCH 12, 2022. H6: HEALTH EFFECT CLINICAL CODE: E2402 REFERS TO CONSUMER "INTENTIONAL MISUSE/OFF-LABEL USE" OF THE PRODUCT. E1721 ALSO REFERS TO CONSUMER ALLEGED ABOUT "SKIN TEAR DUE TO WHICH OPEN WOUND". 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 · 0

    A MALE CONSUMER REPORTED AN EVENT WITH BAND-AID FLEXIBLE FABRIC BANDAGE WHEN USED ON HIS SORES. HE EXPERIENCED IRRITATION AND TORN SKIN ON THE LAST BAND AID HE APPLIED. THE BAND-AID LEFT A BRUISE LIKE A SCAR ON HIS LEG AND AN OPEN WOUND ON HIS ARM. CONSUMER CONTACTED HEALTH CARE PROFESSIONAL (HCP) AND WAS PRESCRIBED MUPRICIN OINTMENT, GAUZE AND BACTRIM PILLS FOR THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583993 BAB FLEXIBLE FABRIC BANDAGES TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 381371150786 220312

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention