BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES

    MDR report key: 13455752 · Received February 4, 2022

    Report

    Report Number
    2214133-2022-00002
    Event Type
    Injury
    Date Received
    February 4, 2022
    Report Date
    January 14, 2022
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    NAD
    UDI-DI
    4901730080156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED FOR TREATMENT. NOT DIAGNOSIS. PATIENT IDENTIFIER, AGE AT TIME OF EVENT, GENDER, WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (BAND AID BRAND KKP JUMBO 3CT (B)(4)). LOT NUMBER IS NOT AVAILABLE. CONCOMITANT MEDICAL PRODUCTS: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. UDI: (B)(4). UPC: 4901730080156. LOT NUMBER IS NOT AVAILABLE. 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

    A CONSUMER HAD BEEN USING BAND AID BRAND KPP (KIZU POWER PAD) BANDAGE ON HIS/HER PAINFUL AREAS DUE TO GOUT (SOLES AND SIDES OF FEET) SINCE ABOUT (B)(6) 2021. WHEN THE CONSUMER REMOVED THE STRIP WITHOUT SOAKING IT IN HOT WATER, THE SKIN PEELED OFF EXTENSIVELY WITH IT, SO THE CONSUMER APPLIED A NEW STRIP AGAIN. THE CONSUMER HAD CONTINUED TO USE KPP SINCE THEN WHILE REPLACING THE STRIP, BUT SOMETIMES CLOTS OF BLOOD WERE NOTED ON THE STRIP WHEN THE CONSUMER REMOVED IT. AT THE TIME OF THIS REPORTING ((B)(6) 2022), THE AFFECTED AREA WAS SWOLLEN AND THE FINGERTIPS AROUND THE AREA WHERE THE STRIP WAS APPLIED WERE ITCHY. THE CONSUMER¿S TOES DID NOT TOUCH THE FLOOR AND COULD NOT WALK. HE WAS TOLD BY ATTENDING PHYSICIAN TO SEE A DERMATOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314835 BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES DRESSING, WOUND, OCCLUSIVE NAD JOHNSON & JOHNSON CONSUMER INC 4901730080156 4901730080156

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention