BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE

    MDR report key: 16561026 · Received March 16, 2023

    Report

    Report Number
    2214133-2023-00008
    Event Type
    Injury
    Date Received
    March 16, 2023
    Date of Event
    February 22, 2023
    Report Date
    March 27, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    NAD
    UDI-DI
    381371172979
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 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 APRIL 01, 2022. RAW MATERIAL AND COMPONENT RECORDS WERE REVIEWED AND WERE FOUND ACCEPTABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    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. YEAR OF BIRTH: 1957. PATIENT WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE 10CT USA 381371172979 8137117297USA 8137117297USA, LOT NUMBER 1362C. UDI #: (B)(4). UPC #: (B)(4). LOT #: 1362C. EXPIRATION DATE - 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. HEALTH EFFECT CLINICAL CODE: E1708 ALSO REFERS TO CONSUMER ALLEGED ABOUT "ITCHINESS IN LEG, AROUND THE BANDAGE AND ITCHINESS IN CHEST". 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 REPORTED AN EVENT WITH BAND AID BRAND HYDROSEAL BANDAGE ALL PURPOSE. THE CONSUMER APPLIED THE PRODUCT FOR A SPOT ON HER LEG BECAUSE OF A BUSH. CONSUMER EXPERIENCED A RED RASH AND ITCHINESS ON HER LEG AROUND THE BANDAGE. IT WAS ALSO REPORTED THAT, IN THE MORNING AFTER APPLICATION, SHE HAD ITCHINESS ON HER CHEST AS WELL. CONSUMER WAS STILL EXPERIENCING SYMPTOMS WHILE REPORTING THIS EVENT AND REMAINED THE SAME. CONSUMER VISITED THE DERMATOLOGIST AND WAS PRESCRIBED TRIAMCINOLONE FOR THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824698 BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE DRESSING, WOUND, OCCLUSIVE NAD JOHNSON & JOHNSON CONSUMER INC 381371172979 1362C 381371172979

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention