BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER

    MDR report key: 24712163 · Received March 30, 2026

    Report

    Report Number
    8041154-2026-00004
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 7, 2026
    Report Date
    March 27, 2026
    Manufacturer
    KENVUE
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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. A4, A5, A6: 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 LARGE ADHESIVE PAD 10CT USA 381370047681 381370047681USA 381370047681USA , LOT NUMBER ¿ NI. D4: 510(K) EXEMPT DEVICE I COMPLAINT. UDI IS NA FOR THIS SUBMISSION. UDI: (B)(4). UPC #381370047681. EXPIRATION DATE: NA. LOT # NI. 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: E172004 ALSO REFERS TO THE CONSUMER ALLEGED ECZEMA/IRRITATION. E0402 ALSO REFERS TO THE CONSUMER ALLEGED INTENTIONAL MISUSE/OFF-LABEL USE OF PRODUCT. IT WAS REPORTED THAT AFTER USING BAND AID BRAND TRU STAY SHEER ADHESIVE PAD ON A SURGICAL INCISION, IRRITATION DEVELOPED AROUND THE WOUND AND WORSENED WITH CONTINUED USE AND PROGRESSED INTO ECZEMA. HCP WAS CONSULTED AND EVENT WAS TREATED WITH ANTIBIOTIC OINTMENT NEOMYCIN. NO REPORT OF HOSPITALIZATION OR ANY SIGNIFICANT MEDICAL TREATMENT OR INTERVENTION. BASED ON THE REVIEW OF THE INFORMATION ABOUT THE EVENT THERE WAS NO HOSPITALIZATION, NO SIGNIFICANT INTERVENTION REPORTED AND NO OTHER SERIOUS 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 63-YEAR-OLD FEMALE CONSUMER REPORTED USING BAND AID BRAND TRU STAY SHEER ADHESIVE PAD ON A SURGICAL INCISION BELOW THE BELLY BUTTON. AFTER APPLICATION, IRRITATION DEVELOPED AROUND THE WOUND AND WORSENED WITH CONTINUED USE, EVENTUALLY PROGRESSING INTO ECZEMA. THE CONSUMER REPORTED SEEKING MEDICAL CARE AND WAS TREATED WITH THE ANTIBIOTIC OINTMENT NEOMYCIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771872 BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER TAPE AND BANDAGE, ADHESIVE KGX KENVUE 381370047681

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention