BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES

    MDR report key: 18708332 · Received February 14, 2024

    Report

    Report Number
    2214133-2024-00008
    Event Type
    Injury
    Date Received
    February 14, 2024
    Report Date
    January 22, 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 & 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. A2: IT WAS REPORTED THAT PATIENT AGE WAS IN HER 30S. EXACT AGE OR DATE OF BIRTH IS UNKNOWN. A4, A5: PATIENT WEIGHT, PATIENT ETHNICITY AND RACE WERE NOT PROVIDED. D1, D2, D3, D4: THIS REPORT IS FOR BAND AID BRAND KIZU POWER PAD UNSPECIFIED AP. 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 USA 381371175338). LOT NUMBER WAS NOT AVAILABLE FOR REPORTING. UDI IS NOT AVAILABLE FOR REPORTING. D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION H3, H4, H6: DEVICE EVALUATION 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-E1902 ALSO REFERS TO CONSUMER ALLEGED ABOUT " MOLD GREW IN PORES". THIS EVENT IS BEING REPORTED AS AN OVERABUNDANCE OF CAUTION. FOLLOWING PRODUCT USE CONSUMER REPORTED MOLDS GREW IN THE PORES. PRODUCT WAS APPLIED ON THE FINGER AND CONSUMER DEVELOPED BUMPS ON THE SIDE OF FINGER. DERMATOLOGIST WAS CONSULTED WHO CONFIRMED THAT MOLD GREW IN THE PORES. NO REPORT OF ANY SIGNIFICANT MEDICAL TREATMENT OR INTERVENTION. BASED ON AVAILABLE INFORMATION, EVENT INTERPRETED AS MOLD INFECTION AT APPLICATION SITE AND CODED TO FUNGAL INFECTION. 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 FEMALE CONSUMER, IN HER 30S, REPORTED AN EVENT REGARDING UNSPECIFIED BAND AID BRAND KIZU POWER PAD (HYDRO SEAL BANDAGE). AROUND THE SPRING OF 2023, WHILE SHE WAS USING THE PRODUCT ON HER FINGER, ABOUT 3 DAYS AFTER SHE APPLIED IT, BUMPS APPEARED ON THE SIDE OF THE FINGER. WHEN SHE VISITED A DERMATOLOGIST, SHE WAS TOLD THAT MOLD GREW IN THE PORES, SO SHE STOPPED USING THE PRODUCT. AT THE TIME OF THE REPORTING, THE SKIN OF THE AREA HAD RETURNED TO NORMAL AND THERE WAS NO PROBLEM. THE SYMPTOMS IMPROVED AFTER THE PATIENT STOPPED USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792168 BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES DRESSING, WOUND, OCCLUSIVE NAD JOHNSON & JOHNSON CONSUMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention