BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER

    MDR report key: 20863223 · Received December 6, 2024

    Report

    Report Number
    8041154-2024-00014
    Event Type
    Injury
    Date Received
    December 6, 2024
    Report Date
    December 6, 2024
    Manufacturer
    KENVUE
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A4, A5, A6: WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) BAND-AID SHEER BANDAGES UNSPECIFIED USA NOTAPPLICABLE BASHBDUSUNSP, LOT NUMBER - NI. 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. H6: E2330 ¿ REFERS THE CONSUMER ALLEGED PAIN. E040203 ¿ REFERS THE CONSUMER ALLEGED THE PRODUCT HAS BURNT LAYERS OF SKIN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CORRECTED SECTION: G1 (FACILITY NAME) FACILITY NAME UPDATE FROM JOHNSON & JOHNSON CONSUMER INC TO KENVUE IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP (01) MEDWATCH, A FOLLOW-UP (02) MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    A 65-YEAR-OLD FEMALE CONSUMER REPORTED THE PRODUCT WAS USED TO COVER A SCRATCHED SPOT. IT WAS REPORTED FOLLOWING USE OF PRODUCT THE CONSUMER WAS IN SEVERE PAIN AND THAT THE SKIN AT THE APPLICATION SITE ¿LOOKED LIKE THE BAND-AID HAS BURNT LAYERS OF SKIN¿. THE CONSUMER CONSULTED HCP AND WAS PRESCRIBED MUPIROCIN OINTMENT TO TRY AND PREVENT INFECTIONS. THE CONSUMER¿S CONDITION HAVE IMPROVED AFTER STOPPED USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2516624 BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER TAPE AND BANDAGE, ADHESIVE KGX KENVUE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention