BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND OF FIRST AID PRODUCTS SELF ADHERING SPORTS WRAP

    MDR report key: 20007526 · Received August 20, 2024

    Report

    Report Number
    2214133-2024-00034
    Event Type
    Injury
    Date Received
    August 20, 2024
    Date of Event
    July 25, 2024
    Report Date
    July 26, 2024
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    FQM
    UDI-DI
    381372022815
    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 & 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 AN 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. A5: WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D4: THIS REPORT IS FOR ONE (BAND AID BRAND OF FIRST AID PRODUCTS SELF ADHERING SPORTS WRAP 2 IN 1CT USA 381372022815, 381372022815, 381372022815, USA, LOT/CTRL # NI). D4: UDI #: (B)(4). UPC #: 381372022815, LOT #: NI, EXPIRATION DATE: NI. D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. H6: HEALTH EFFECT CLINICAL CODE: E0402 REFERS TO ALLERGIC REACTION, CONSUMER ALLEGED PRODUCT CAUSED SKIN RASHES. 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 MOTHER OF A 15-YEAR-OLD FEMALE CONSUMER REPORTED AN EVENT WITH BAB FIRST AID PRODUCTS SELF ADHERING SPORTS WRAP. CONSUMER REPORTED THAT HER DAUGHTER APPLIED ONE WRAP ON (B)(6) 2024 TO COVER THE WOUND LIKE A CUT AND ON THE SAME DAY HER DAUGHTER GOT SKIN RASHES. CONSUME SOUGHT MEDICAL INTERVENTION AND HEALTH CARE PROVIDED GAVE HER TRIAMCINOLONE ACETONIDE ANTI-BIOTIC CREAM AND DERMATOLOGY FASTING. CONSUMER STOPPED USING THE PRODUCT AND HER SYMPTOMS HAVE STAYED THE SAME AT THE TIME OF THIS REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992703 BAND AID BRAND OF FIRST AID PRODUCTS SELF ADHERING SPORTS WRAP BANDAGE, ELASTIC FQM JOHNSON & JOHNSON CONSUMER INC 381372022815 381372022815

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Required Intervention