BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES

    MDR report key: 22555914 · Received July 21, 2025

    Report

    Report Number
    2214133-2025-00012
    Event Type
    Injury
    Date Received
    July 21, 2025
    Date of Event
    July 6, 2025
    Report Date
    July 21, 2025
    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. A1, A2, A3, A4, A5: PATIENT INITIALS, AGE, SEX, GENDER, WEIGHT, ETHNICITY AND RACE WERE NOT AVAILABLE FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) BAND AID BRAND KIZU POWER PAD UNSPECIFIED AP NOTAPPLICABLE 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 381371175338 8137117533USA 8137117533USA). LOT NUMBER WAS NOT AVAILABLE FOR REPORTING. D4: 510(K) EXEMPT DEVICE I COMPLAINT. UDI, UPC, LOT NUMBER AND EXPIRATION DATE ARE NOT AVAILABLE FOR REPORTING. D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. FOLLOWING USE OF PRODUCT CONSUMER DEVELOPED ITCHING AND REDNESS AT THE SITE OF APPLICATION. IT WAS REPORTED THAT THE CONSUMER WENT TO HOSPITAL (INTERPRETED AS VISIT) BUT NO DETAILS OF TREATMENT REPORTED. BASED ON AVAILABLE INFORMATION, NO HOSPITALIZATION OR SIGNIFICANT INTERVENTION REPORTED. 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 REPORTED AN EVENT WITH BAND-AID BRAND KIZU POWER PAD BANDAGES. CONSUMER STARTED USING THE PRODUCT ON (B)(6) 2025. ON THE SAME DAY OF USING BAND-AID BRAND KIZU POWER PAD BANDAGE, THE CONSUMER FELT ITCHY, AND SKIN WAS RED UPON REMOVAL OF THE BANDAGE. THE CONSUMER STATED THAT THEY WENT TO THE HOSPITAL HOWEVER NO DETAILS OF TREATMENT WERE REPORTED. THERE IS NO ADDITIONAL INFORMATION WITH REGARDS TO THE OUTCOME FOR THIS CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871325 BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES DRESSING, WOUND, OCCLUSIVE NAD KENVUE BRANDS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention