BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID CLEAR BANDAGES

    MDR report key: 16426574 · Received February 23, 2023

    Report

    Report Number
    1000599868-2023-00002
    Event Type
    Injury
    Date Received
    February 23, 2023
    Date of Event
    December 27, 2022
    Report Date
    February 1, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    9300607171815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. AGE OR DATE OF BIRTH: YEAR OF BIRTH: 1946. WEIGHT, ETHNICITY: PATIENT IDENTIFIER, WEIGHT, PATIENT ETHNICITY AND RACE WERE NOT PROVIDED. THIS REPORT IS FOR BAND AID BRAND CLEAR STRIPS 40CT AP 9300607171815 9300607171815APA 9300607171815APA . DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAB PERFECT BLEND CLEAR LIGHT ASST 45S USA 381370057017 8137005701USD 8137005701USD). UDI#: (B)(4). UPC: 9300607171815. LOT NUMBER: 210924. EXPIRATION DATE - 08/24/2024. CONCOMITANT MEDICAL PRODUCTS: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION 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 24,2021. HEALTH EFFECT CLINICAL CODE: E0402 ALSO REFERS TO CONSUMER ALLEGED ABOUT " RASH SUBSUMED UNDER ALLERGY, INTENSE REACTION SPREAD OVER ENTIRE BODY(HAIR, BETWEEN TOES) ". 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 CONSUMER REPORTED AN EVENT WITH BAND AID BRAND CLEAR STRIP. CONSUMER APPLIED STRIP FOR A SMALL TEAR IN THE SKIN AND HAD SOME RASHES. THE INTENSE REACTION SPREAD OVER HER ENTIRE BODY. IT WAS IN HER HAIR, BETWEEN TOES BASICALLY IT MIGRATED ALL OVER MY BODY. BY DAY 2 AFTER VISITING A DOCTOR CONSUMER STARTED TAKING, ANTIHISTAMINES, PRESCRIBED STEROIDS AND APPLYING BETAMETHASONE 0.02MG/G REGULARLY. THE DOCTOR ALSO RECOMMENDED, RUBBING ICE ON THE BODY. IT WAS REPORTED THAT, THE REACTION GRADUALLY SUBSIDED OVER THE NEXT 4 DAYS. THE SKIN HAD RETURNED TO NORMAL WITH NO PIGMENT CHANGES OR SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576793 BAND AID CLEAR BANDAGES TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 9300607171815 212924 9300607171815

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention