BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES

    MDR report key: 16852450 · Received May 2, 2023

    Report

    Report Number
    2214133-2023-00011
    Event Type
    Injury
    Date Received
    May 2, 2023
    Date of Event
    April 6, 2023
    Report Date
    April 7, 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

    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 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 (B)(4). D4: UPC, LOT NUMBER AND UDI# ARE NOT AVAILABLE. D10: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H6: HEALTH EFFECT CLINICAL CODE: E1721 ALSO REFERS TO CONSUMER ALLEGED ABOUT "EVEN THE HEALTHY SKIN PEELED OFF SUBSUMED REDNESS" E1707 ALSO REFER TO CONSUMER ALLEGED ABOUT "THE WOUND, WHICH WAS ORIGINALLY ABOUT 5 MM, GREW TO ABOUT 1 CM (WOUND WORSE)" E040203 ALSO REFER TO CONSUMER ALLEGED ABOUT "HEALTHY SKIN LOOKED TO BE MELTED" E2402 REFERS TO CONSUMER "INTENTIONAL MISUSE/OFF-LABEL USE" OF THE PRODUCT AND FOR USED ON CRUSHED THE LESION 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. 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 APPLIED BAND AID BRAND KIZU POWER PAD TO WOUND THAT WAS LIKE A BOIL, CRUSHED AND TORN. ON THE NIGHT OF THE SAME DAY, THE CONSUMER FELT A CHILL. CONSUMER TOOK HIS/HER TEMPERATURE, IT WAS OVER 37.5 DEGREES. THE CONSUMER STATED THAT THE APPLICATION SITE OF THE PRODUCT HAD TURNED BRIGHT RED. ON THE DAY OF THIS REPORTING, CONSUMER VISITED A HOSPITAL. ACCORDING TO THE CONSUMER, THE WOUND, WHICH WAS ORIGINALLY ABOUT 5 MM, GREW TO ABOUT 1 CM, AND EVEN THE HEALTHY SKIN PEELED OFF AND LOOKED TO BE MELTED. THE CONSUMER WAS TOLD BY A PHYSICIAN AT THE HOSPITAL THAT IT WAS UNKNOWN WHETHER THE SYMPTOM WAS DUE TO THE PRODUCT. CONSUMER WAS STILL EXPERIENCING THE SYMPTOMS WHILE REPORTING THIS EVENT. IT WAS REPORTED THAT, CONSUMER VISITED HOSPITAL FOR UNKNOWN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247674 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