BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES

    MDR report key: 19417483 · Received May 29, 2024

    Report

    Report Number
    2214133-2024-00025
    Event Type
    Injury
    Date Received
    May 29, 2024
    Report Date
    May 20, 2024
    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 & AMP; 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 & AMP; JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR (BAND AID BRAND KIZU POWER PAD (KPP) LARGE 6CT AP 4901730021913 4901730021913APB 4901730021913APB). 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 IS NOT AVAILABLE FOR REPORTING. D4: UDI #: (B)(4). UPC: 4901730021913 EXPIRATION DATE: NI LOT #: NI 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. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. HEALTH EFFECT CLINICAL CODE: E2402 REFERS TO CONSUMER & QUOT; INTENTIONAL MISUSE/OFF-LABEL USE & QUOT; 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 HE/SHE GOT A BURN WOUND BECAUSE HE/SHE TOUCHED A POT, AND A BLISTER DEVELOPED. SINCE HE/SHE THOUGHT THAT BLISTERS WERE INCLUDED IN MILD BURN WOUNDS, HE/SHE USED THE BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES AND THEN THROBBING PAIN STARTED TO DEVELOP. WHEN HE/SHE CALLED CALL CENTER, HE/SHE WAS TOLD THAT THE PRODUCT COULD NOT BE USED ON BLISTERS AND THAT HE/SHE SHOULD CONSULT A DOCTOR. HE/SHE WAS UNABLE TO GET AN APPOINTMENT AT A NEARBY DERMATOLOGIST THAT DAY, AND THUS HE/SHE VISITED A DERMATOLOGIST THE NEXT DAY. THE DERMATOLOGIST TOLD HIM/HER TO STOP USING THE PRODUCT, PRESCRIBED AN OINTMENT, AND INSTRUCTED HIM/HER TO USE CARELEAVES (OTHER MANUFACTURER¿S ADHESIVE BANDAGE) HEREAFTER. THE DERMATOLOGIST ALSO TOLD HIM/HER ¿THE BURN WOUND HAS REACHED THE DERMIS. IT WILL TAKE ABOUT TWO WEEKS TO FULLY HEAL. IF YOU HAD COME SOONER, IT WOULD HAVE HEALED IN LESS TIME. HE/SHE USED THE OINTMENT, AND THE SYMPTOM WAS GETTING A LITTLE BETTER AS OF THIS REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630286 BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES DRESSING, WOUND, OCCLUSIVE NAD JOHNSON & JOHNSON CONSUMER INC 4901730021913

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention