BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER

    MDR report key: 17087402 · Received June 8, 2023

    Report

    Report Number
    8041154-2023-00012
    Event Type
    Injury
    Date Received
    June 8, 2023
    Date of Event
    May 13, 2023
    Report Date
    May 15, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    381370046660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. A2: PATIENT WAS 8 YEARS OLD AT TIME OF EVENT. A4, A5: 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 SHEER BANDAGES 40CT USA 381370046660 381370046660USA 381370046660USA, LOT NUMBER IS NOT AVAILABLE. D4: UDI: (B)(4). UPC = 381370046660. EXPIRATION DATE= NI. LOT NUMBER = NA. D10: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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 LOT NUMBER. HEALTH EFFECT CLINICAL CODE: E0402 ALSO REFERS TO CONSUMER ALLEGED ABOUT DIAGNOSED BY HCP AS ALLERGIC REACTION SUBSUMED BURNING. E1707 ALSO REFERS TO CONSUMER ALLEGED ABOUT "MADE BIG BITE WORSE". E2402 REFERS TO CONSUMER INTENTIONAL MISUSE/OFF-LABEL USE OF 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

    CONSUMER'S PARENT REPORTED THAT HER 8 YEAR OLD SON USED BAND AID BRAND TRU STAY SHEER BANDAGE TO COVER A SMALL INSECT BITE ON (B)(6) 2023. SAME DAY THE BANDAGE WAS REMOVED BY PARENT BECAUSE HER CHILD COMPLAINED OF BURNING AND THAT IT MADE HIS BIG BITE WORSE. THE PARENT TOOK HER CHILD TO THE DOCTOR WHO NOTICED BLISTERS WHERE THE BANDAGE WAS APPLIED. THE DOCTOR¿S OPINION WAS THAT THE PATIENT IS ALLERGIC TO PRODUCT. CONSUMER'S PARENT REPORTED THAT A STEROID CREAM AND ANTIBIOTIC RX CREAM WERE PRESCRIBED BY THE HEALTH CARE PROFESSIONAL AND USED TO TREAT THE REACTION. THE SYMPTOMS HAVE IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275892 BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 381370046660 381370046660

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male Required Intervention