BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES

    MDR report key: 24769122 · Received April 2, 2026

    Report

    Report Number
    2214133-2026-00005
    Event Type
    Injury
    Date Received
    April 2, 2026
    Report Date
    April 2, 2026
    Manufacturer
    KENVUE BRANDS, LLC
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    KENVUE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH KENVUE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, KENVUE OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, KENVUE, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IN AUGUST 2023 JOHNSON & JOHNSON¿S CONSUMER HEALTH BUSINESS SEPARATED FROM JOHNSON & JOHNSON, AND WE BECAME AN INDEPENDENT PUBLIC COMPANY, KENVUE. AS PART OF OUR ONGOING EVOLUTION, KENVUE UPDATED THE NAME OF ITS US OPERATING COMPANY, JOHNSON & JOHNSON CONSUMER INC. (JJCI) TO KENVUE BRANDS LLC ON OCTOBER 28, 2024. KENVUE RECENTLY MOVED TO ITS NEW CORPORATE HEADQUARTERS IN SUMMIT NJ. ITS PREVIOUS CORPORATE HEADQUARTERS WAS 199 GRANDVIEW ROAD, SKILLMAN, NJ 08558. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A4, A5 AND A6: PATIENT WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. 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 381371175338 8137117533USA. LOT NUMBER WAS NOT AVAILABLE FOR REPORTING. UDI IS NOT AVAILABLE FOR REPORTING. D4: 510(K) EXEMPT DEVICE I COMPLAINT. UDI AND LOT NUMBER ARE NOT AVAILABLE FOR REPORTING. D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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. H6: E172004 - CONSUMER ALLEGED RED, ITCHING, ITCHY ECZEMA ON BODY THAT SPREAD ALL OVER. E2402 - CONSUMER MISUSE/OFF-LABEL USE - INTENTIONAL. THE CONSUMER APPLIED THE PRODUCT THREE DAYS AFTER THE INJURY AND REPORTED THAT THE AREA AROUND THE WOUND WHERE THE PRODUCT HAD BEEN APPLIED TURNED SLIGHTLY RED, AND THERE WAS SOME ITCHING FOLLOWING WHICH HE REPORTED DEVELOPING AN ITCHY ECZEMA ON MY BODY THAT SPREAD ALL OVER. CONSUMER CONSULTED DERMATOLOGIST WHO TOLD HIM THAT THE ECZEMA WAS CAUSED BY THE PRODUCT. BASED ON OVERALL DETAILS, EVENT INTERPRETED AS ECZEMA (SUBSUMED RED AND ITCHING). THE DOCTOR PRESCRIBED ORAL AND TOPICAL MEDICATIONS. BASED ON AVAILABLE INFORMATION, NO IME, NO HOSPITALIZATION, NO SIGNIFICANT INTERVENTION REPORTED AND NO OTHER SERIOUSNESS CRITERIA MET. IF ADDITIONAL 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 69-YEAR-OLD MALE APPLIED BAND BRAND KIZU PAD TO AN INJURY THREE DAYS AFTER IT OCCURRED. CONSUMER REPORTED MILD REDNESS AND ITCHING AT THE APPLICATION SITE AFTER REMOVING THE PRODUCT AND THE ITCHING SPREAD ALL OVER HIS BODY. CONSUMER CONSULTED A DERMATOLOGIST, WHO ATTRIBUTED THE ITCHING TO ECZEMA CAUSED BY THE PRODUCT. CONSUMER WAS PRESCRIBED ORAL ANTI-ITCH MEDICATION DESALEX, A MIXTURE OF CLOBETASOL PROPIONATE OINTMENT, AS WELL AS A TOPICAL OINTMENT MIXTURE OF HIRUDOID CREAM, AND UREA CREAM TO TREAT THE EVENT. CONSUMER REPORTED THE SYMPTOMS HAVE NOT CURED IMMEDIATELY BUT HAVE IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828215 BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES DRESSING, WOUND, OCCLUSIVE NAD KENVUE BRANDS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention