BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND TRU STAY PLASTIC BANDAGES

    MDR report key: 16846862 · Received May 1, 2023

    Report

    Report Number
    8041154-2023-00008
    Event Type
    Injury
    Date Received
    May 1, 2023
    Date of Event
    April 5, 2023
    Report Date
    April 6, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    381370056355
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 & 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. A2, A4, A5: 77 YEARS OLD; PATIENT WEIGHT AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) BAND AID BRAND TRU STAY PLASTIC BANDAGES 60CT USA 381370056355 381370056355USD 381370056355USD, LOT NUMBER: 2692B. D4: UDI#: (B)(4). UPC#: 381370056355, LOT#: 2692B, EXPIRATION DATE: NA. D10: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 26, 2022. H6: HEALTH EFFECT CLINICAL CODE: E1721 ALSO REFERS TO CONSUMER ALLEGED ABOUT "LOST WHOLE BIG TOE NAIL BECAUSE OF THIS BAND-AID & QUOT; E2402 REFERS TO CONSUMER "INTENTIONAL MISUSE/OFF-LABEL USE & QUOT; OF THE PRODUCT AND FOR WENT TO THE DOCTOR AND HAD TO PUT ON ANTIBIOTIC AND PUT THE PRODUCT. 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 FEMALE 77 YEAR OLD CONSUMER REPORTED AN EVENT WITH BAND AID BRAND TRU STAY PLASTIC BANDAGE. THE CONSUMER PUT ANTIBIOTIC ON A BROKEN TOE NAIL AND PUT THE BANDAGE ON IT. THE CONSUMER EXPERIENCED AN INFECTION IN FOOT AND REPORTED SHE ¿LOST WHOLE BIG TOE NAIL BECAUSE OF THIS BAND-AID¿. A HEALTH CARE PROFESSIONAL (HCP) WAS CONSULTED WHO ¿TOOK WHOLE TOE NAIL¿. SINCE STOPPING USE OF PRODUCT AND TREATMENT, THE SYMPTOMS HAVE IMPROVED FOR THE CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566304 BAND AID BRAND TRU STAY PLASTIC BANDAGES TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 381370056355 2692B 381370056355

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention