BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND ADHESIVE BANDAGES WATERPROOF CLEAR

    MDR report key: 22917026 · Received August 28, 2025

    Report

    Report Number
    2214133-2025-00015
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    August 15, 2025
    Report Date
    August 28, 2025
    Manufacturer
    KENVUE BRANDS, LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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 & AMP; JOHNSON¿S CONSUMER HEALTH BUSINESS SEPARATED FROM JOHNSON & AMP; 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 & AMP; 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 ONE (1) BAND AID BRAND ADHESIVE BANDAGES WATERPROOF CLEAR JUMBO 6CT USA 381372025243 381372025243USA, LOT NUMBER: NI. D4: 510(K) EXEMPT DEVICE I COMPLAINT. UDI IS NA FOR THIS SUBMISSION. UDI: (B)(4), UPC #: 381372025243, EXPIRATION DATE: NA, LOT#: NI. 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: E1721 ALSO REFERS TO THE CONSUMER ALLEGED FOR & QUOT; TORE OFF THE TOP LAYER OF SKIN & QUOT. IT WAS REPORTED THAT ON REMOVING THE PRODUCT, IT ¿TORE OFF THE TOP LAYER OF SKIN¿/¿ SOME OF THE SKIN AROUND THE PERIMETER OF THE WOUND WAS TORN OFF¿ (EVENT INTERPRETED AS SKIN TEAR). CONSUMER CONSULTED HCP AT A WOUND CARE UNIT. CONSUMER REPORTED PRODUCT TORE OF THE TOP LAYER OF THE SKIN. HCP WAS CONSULTED AND EVENT WAS TREATED WITH APPLICATION OF AQUA CELL AG. NO REPORT OF HOSPITALIZATION OR ANY SIGNIFICANT MEDICAL TREATMENT OR INTERVENTION. THERE WAS NO REPORT OF ANY EXCESSIVE BLEEDING NOR ANY SURGICAL/INVASIVE INTERVENTION REPORTED. BASED ON THE REVIEW OF THE EVENT INFORMATION THERE WAS 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 76-YEAR-OLD MALE CONSUMER REPORTED USING BAND AID BRAND ADHESIVE BANDAGES WATERPROOF CLEAR JUMBO BANDAGE. CONSUMER ALLEGED THAT THE PRODUCT TORE THE TOP LAYER OF SKIN OFF LOWER LEG AND THE SKIN AROUND THE PERIMETER OF THE WOUND. THE CONSUMER REPORTED HE CONSULTED A HEALTH CARE PROFESSIONAL (HCP) AT A HOSPITAL & (B)(6) WOUND CARE UNIT AND CONSUMER WAS TOLD TO APPLY AQUACEL AG TO PREVENT SCABS FROM FORMING. CONSUMER STATED HIS CONDITION HAS REMAINED THE SAME. NO FURTHER TREATMENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188814 BAND AID BRAND ADHESIVE BANDAGES WATERPROOF CLEAR TAPE AND BANDAGE, ADHESIVE KGX KENVUE BRANDS, LLC 381372025243

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention