BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER

    MDR report key: 21388086 · Received February 14, 2025

    Report

    Report Number
    8041154-2025-00001
    Event Type
    Injury
    Date Received
    February 14, 2025
    Report Date
    February 14, 2025
    Manufacturer
    KENVUE BRANDS, LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 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. A5, A5: PATIENT WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) BAND AID BRAND TRU STAY SHEER BANDAGES 80CT USA 381370046691 381370046691USA, LOT NUMBER NI. D4: 510(K) EXEMPT DEVICE I COMPLAINT. UPC 381370046691 LOT NUMBER: NI EXPIRATION DATE: NA 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. H6: E040203 REFERS TO THE CONSUMER ALLEGED PHYSICAL SKIN REACTION OF LEAVING A PERMANENT MARK ON THE WOUND; E1715 REFERS TO THE CONSUMER ALLEGED SCAR; E1704 REFERS TO THE CONSUMER ALLEGED BURN. F11: REFERS TO MINOR INJURY/ ILLNESS / IMPAIRMENT. CONSUMER USED THE PRODUCT ON A ¿BURN WOUND¿ (INTERPRETED AS MISUSE) AND REPORTED THAT ¿BAND-AID LEAVES ADHESIVE LIKE A RING AROUND THE ACTUAL SCAR¿ WHICH WAS ALSO DESCRIBED AS ¿BAND-AID ITSELF HAD LEFT A PERMANENT MARK ON THE WOUND¿/¿ THE OUTLINE OF WHERE THE BAND-AID WAS PLACED IS STILL VISIBLE ON SKIN¿. CONSUMER CONSULTED HCP AND USED A ¿SCAR OINTMENT¿. BASED ON OVERALL DETAILS REPORTED, EVENT OF LOCAL REACTION WAS CONSIDERED IN ADDITION TO THE EVENT OF SCARRING AS IT WAS REPORTED THAT THE ¿PERMANENT MARK¿/¿ ADHESIVE LIKE A RING¿ WAS AROUND THE " ACTUAL SCAR" NO REPORT OF MORE THAN 2-YEAR-OLD SCAR IN AVAILABLE INFORMATION. NO HOSPITALIZATION, NO SIGNIFICANT INTERVENTION REPORTED AND NO OTHER SERIOUSNESS CRITERIA MET. 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 34 YEAR OLD FEMALE CONSUMER REPORTED AN EVENT WITH BAND AID BRAND TRU STAY SHEER BANDAGE. CONSUMER ALLEGED THAT THE PRODUCT HAD LEFT A PERMANENT MARK AROUND THE WOUND AFTER TWO WEEKS OF USING THE BANDAGE TO COVER A BURN. THE CONSUMER STATED THAT ¿I NOTICED THE BAND-AID BURN MY ARM AND LEFT A SCAR ON MY ARM. BAND-AID LEAVES ADHESIVE LIKE A RING AROUND THE ACTUAL SCAR.¿ WHICH WAS ALSO DESCRIBED AS ¿THE OUTLINE OF WHERE THE BAND-AID WAS PLACED IS STILL VISIBLE ON SKIN.¿ THE CONSUMER SOUGHT MEDICAL ATTENTION FROM A HEALTH CARE PROFESSIONAL AND CONSULTATION WAS REPORTED TO USE UNSPECIFIED PRESCRIPTION OINTMENT TO TREAT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152010 BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER TAPE AND BANDAGE, ADHESIVE KGX KENVUE BRANDS, LLC 381370046691

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention TOPICAL CVS SCAR OINTMENT &QUOT,FOR THE SCAR&QUOT,