BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES

    MDR report key: 17744658 · Received September 14, 2023

    Report

    Report Number
    2214133-2023-00029
    Event Type
    Injury
    Date Received
    September 14, 2023
    Report Date
    August 23, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: 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, PATIENT AGE, GENDER, WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) BAND AID BRAND KIZU POWER PAD UNSPECIFIED AP NOT APPLICABLE RGEBABKAPA RGEBABKAPA. 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). LOT NUMBER- NI. D4: UDI, UPC, LOT NUMBER AND EXPIRATION DATE ARE NOT AVAILABLE. 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 THIS IS 2 OF 2 MED-WATCHES BEING SUBMITTED AS TWO DEVICES SUCH AS BAND AID BRAND KIZU POWER PAD UNSPECIFIED AND RANGE - ADHESIVE BANDAGES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2023-00028 FOR RANGE - ADHESIVE BANDAGES. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. 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 CONSUMER REPORTED AN EVENT WITH BAND AID BRAND KIZU POWER PAD. CONSUMER REPORTED THAT THE BLEEDING WAS STOPPED AFTER PRODUCT USE OF UNSPECIFIED RANGE ADHESIVE BANDAGE STRIP. ON THE NIGHT OF THE SAME DATE, THE CONSUMER REPLACED UNSPECIFIED RANGE ADHESIVE BANDAGE STRIP WITH A SCRATCH POWER PAD. THE NEXT DAY BLEEDING OCCURRED FROM THE WOUND AND DID NOT STOP EASILY. CONSUMER WENT TO THE HOSPITAL AND THE WOUND WAS TREATED AND STITCHED/SEWN UP. THIS IS 2 OF 2 MED-WATCHES BEING SUBMITTED AS TWO DEVICES SUCH AS BAND AID BRAND KIZU POWER PAD UNSPECIFIED AND RANGE - ADHESIVE BANDAGES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2023-00028 FOR RANGE - ADHESIVE BANDAGES. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390941 BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES DRESSING, WOUND, OCCLUSIVE NAD JOHNSON & JOHNSON CONSUMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H