BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES

    MDR report key: 23423047 · Received October 30, 2025

    Report

    Report Number
    2214133-2025-00017
    Event Type
    Injury
    Date Received
    October 30, 2025
    Report Date
    October 30, 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 NOT APPLICABLE (B)(4). 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 (B)(4)). LOT NUMBER - NI. D4: 510(K) EXEMPT DEVICE I COMPLAINT. UPC, 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: E1707 REFERS TO THE CONSUMER ALLEGED FOR SCRAPE WORSENED (DELAYED HEALING) E2402 REFERS TO CONSUMER "INTENTIONAL MISUSE/OFF-LABEL USE" OF THE PRODUCT. THE PRODUCT WAS APPLIED ON A ¿SCRAPE¿ WITHOUT WASHING IT FOLLOWING WHICH IT WAS REPORTED THAT THE ¿SCRAPE WORSENED¿. THE CONSUMER WENT TO A DOCTOR AND WAS PRESCRIBED AN UNSPECIFIED MEDICATION (ROUTE NOT SPECIFIED; INTERPRETED AS ORAL/TOPICAL) AND ¿GAUZE¿ BUT THE CONSUMER ¿THOUGHT THE PRODUCT WAS BETTER, SO I APPLIED IT AGAIN¿ (EVENTS INTERPRETED AS IMPAIRED HEALING AND MISUSE). BASED ON AVAILABLE INFORMATION, NO IME, NO HOSPITALIZATION, NO SIGNIFICANT INTERVENTION REPORTED AND NO OTHER SERIOUSNESS CRITERIA MET. WILL REASSESS ON RECEIPT OF ADDITIONAL DETAILS ABOUT PRODUCT USAGE AND DURATION OF USE, EVENTS ATTRIBUTED TO PRODUCT USE, TREATMENT RECEIVED, HCP DIAGNOSIS IF ANY, EVENT OUTCOME, UNDERLYING MEDICAL HISTORY AND CONCOMITANTS IF ANY. 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 WHICH WAS APPLIED TO SCRATCHES WITHOUT WASHING IT. THE PRODUCT WAS APPLIED ON A SCRAPE WITHOUT WASHING IT FOLLOWING WHICH IT WAS REPORTED THAT THE SCRAPE WORSENED. THE CONSUMER WENT TO A DOCTOR AND WAS PRESCRIBED AN UNSPECIFIED MEDICATION (ROUTE NOT SPECIFIED; INTERPRETED AS ORAL/TOPICAL) AND GAUZE BUT THE CONSUMER THOUGHT THE PRODUCT WAS BETTER, SO THE CONSUMER APPLIED IT AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297989 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