BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES

    MDR report key: 23696618 · Received December 2, 2025

    Report

    Report Number
    2214133-2025-00018
    Event Type
    Injury
    Date Received
    December 2, 2025
    Report Date
    December 2, 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 AND 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, A6: PATIENT IDENTIFIER, AGE, SEX, WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) BAND AID BRAND KIZU POWER PAD UNSPECIFIED AP NOTAPPLICABLE RGEBABKAPA RGEBABKAPA. LOT NUMBER - NI. 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). 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 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. E1719 ¿ REFERS TO REPORTED "SUPPURATION REACHING THE TENDON IS NOTED (TENDON INFECTION)" E1719 ¿ REFERS TO REPORTED "SUPPURATION (SKIN INFECTION)" F12 - REFERS TO SERIOUS INJURY/ILLNESS/IMPAIRMENT. F11 - REFERS TO MINOR INJURY/ILLNESS/IMPAIRMENT. THIS EVENT IS BEING REPORTED AS AN OVER ABUNDANCE OF CAUTION. AT THIS TIME, THERE IS NO CAUSALITY RELATED BETWEEN THE EVENT AND DEVICE NOR HAS THERE BEEN ANY CONFIRMED INTERVENTION. IT WAS REPORTED THAT " A PERSON WITH SUPPURATION CAME AGAIN. SUPPURATION REACHING THE TENDON IS NOTED, AND SO THERE' S NO CHOICE BUT TO DO SURGERY." WHICH WAS INTERPRETED AS INITIAL INFECTION AT THE SITE OF APPLICATION SPREADING AND LEADING TO NEARBY " TENDON INFECTION" WHICH IS ASSESSED AS SERIOUS, SEVERITY MODERATE FOR " TENDON INFECTION" " SO THERE' S NO CHOICE BUT TO DO SURGERY" WAS A FUTURISTIC STATEMENT, NO CONFIRMED REPORT OF ANY SURGICAL INTERVENTION TO HAVE ALREADY BEEN PERFORMED IN AVAILABLE INFORMATION. NO SERIOUSNESS CRITERIA MET FOR INITIAL INFECTION AT THE SITE OF APPLICATION THUS IS ASSESSED AS NON-SERIOUS, SEVERITY MINOR; CAUSALITY NOT RELATED FOR BOTH EVENTS. WILL REASSESS ON RECEIPT OF ADDITIONAL DETAILS ABOUT PRODUCT USAGE AND DURATION OF USE, EVENTS ATTRIBUTED TO PRODUCT USE, TREATMENT TAKEN, HCP CONSULT, INVESTIGATIONS DONE, 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

    AN ADVERSE EVENT WAS REPORTED FOR UNSPECIFIED BAND AID BRAND KIZU BANDAGE. IT WAS REPORTED THAT "A PERSON WITH SUPPURATION CAME AGAIN. SUPPURATION REACHING THE TENDON IS NOTED, AND SO THERE' S NO CHOICE BUT TO DO SURGERY". THIS EVENT WAS INTERPRETED AS INITIAL INFECTION AT THE SITE OF APPLICATION SPREADING AND LEADING TO NEARBY "TENDON INFECTION". "SO THERE' S NO CHOICE BUT TO DO SURGERY" WAS A FUTURISTIC STATEMENT, NO CONFIRMED REPORT OF ANY SURGICAL INTERVENTION TO HAVE ALREADY BEEN PERFORMED IN AVAILABLE INFORMATION. AT THIS TIME, THERE IS NO CAUSALITY RELATED BETWEEN THE EVENT AND DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958559 BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES DRESSING, WOUND, OCCLUSIVE NAD KENVUE BRANDS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R