BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES

    MDR report key: 17098154 · Received June 9, 2023

    Report

    Report Number
    2214133-2023-00017
    Event Type
    Injury
    Date Received
    June 9, 2023
    Report Date
    May 18, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    NAD
    UDI-DI
    4901730180450
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. A1, A2, A3, A4, A5: PATIENT IDENTIFIER, AGE AT TIME OF EVENT, GENDER, WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR (BAND-AID KIZU POWER PAD PLUS BIG SIZE 6CT AP 4901730180450 79606722APA 79606722APA). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE 1CT USA 381371175338 8137117533USA 8137117533USA). D4: UDI#: (B)(4). UPC: 4901730021913. LOT NUMBER: NI. EXPIRATION DATE: NI. 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. H6: HEALTH EFFECT CLINICAL CODE: 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 REPORTED AN EVENT WITH THE BAND-AID KIZU POWER PAD PLUS BIG SIZE. THE CONSUMER INJURED LEFT ELBOW AND APPLIED OTHER UNKNOWN MANUFACTURE'S PRODUCT WHILE AT HOME. AFTER THE CONSUMER USED UP THE OTHER MANUFACTURE'S PRODUCT, THE CONSUMER PURCHASED AND APPLIED THE BAND-AID KIZU POWER PAD PLUS BIG SIZE. AFTER THAT, REDNESS, SWELLING, AND ITCHING DEVELOPED ON SKIN PART WHERE THERE WAS NO WOUND. THE CONSUMER STOPPED USING THE PRODUCT AND SOUGHT MEDICAL ATTENTION FROM A DOCTOR. THE DOCTOR PRESCRIBED AN UNKNOWN TOPICAL CREAM. AS OF THIS REPORTING, ITCHING SUBSIDED, BUT REDNESS PERSISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188392 BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES DRESSING, WOUND, OCCLUSIVE NAD JOHNSON & JOHNSON CONSUMER INC 4901730180450 4901730180450

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention