BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER

    MDR report key: 23999366 · Received January 7, 2026

    Report

    Report Number
    8041154-2026-00001
    Event Type
    Injury
    Date Received
    January 7, 2026
    Date of Event
    December 6, 2025
    Report Date
    January 22, 2026
    Manufacturer
    KENVUE BRANDS, LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. 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¿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

    Additional Manufacturer Narrative · 0

    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: ETHNICITY WAS 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 381370046691USA, LOT NUMBER ¿ 1265B. D4: 510(K) EXEMPT, DEVICE I COMPLAINT. UDI IS NOT REQUIRED. UDI: (B)(4), UPC: 381370046691 , EXPIRATION DATE: NA, LOT # 1265B. D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION D10: OTHER (NON-KENVUE) CONCOMITANT PRODUCTS USED: ATORVASTATIN, START DATE: UNKNOWN, PRODUCT STOP DATE: UNKNOWN. LEVOTHYROXINE , START DATE: UNKNOWN, PRODUCT STOP DATE: UNKNOWN. LOSARTAN, START DATE: UNKNOWN, PRODUCT STOP DATE: UNKNOWN. METFORMIN, START DATE: UNKNOWN, PRODUCT STOP DATE: UNKNOWN. H3, H4, H6: DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. H6: E170404 REFERS TO THE CONSUMER ALLEGED FOR SUPERFICIAL (FIRST DEGREE) BURN/HAD A BURN/SUSTAINED CHEMICAL BURNS (CHEMICAL) E2402 REFERS TO CONSUMER " INTENTIONAL MISUSE/OFF-LABEL USE" OF THE PRODUCT. F12 - REFERS TO SERIOUS INJURY/ILLNESS/IMPAIRMENT. VOLUNTARY MW5180287 WAS RECEIVED ON 05-JAN-2026. IN THIS REPORT, THE CONSUMER ALLEGED A SERIOUS INJURY. THIS CASE IS BEING REPORTED OUT OF AN OVER ABUNDANCE OF CAUTION. THE CONSUMER USED THE PRODUCT TO ¿PROTECT A LESION ON STOMACH¿ (INTERPRETED AS MISUSE) AND REPORTED HAVING ¿A BURN ON SKIN¿; CONSUMER ALSO MENTIONED THAT SHE ¿SUSTAINED CHEMICAL BURNS ON SKIN¿ (EVENT INTERPRETED AS CHEMICAL BURN ON SKIN, CODED TO SUPERFICIAL (FIRST DEGREE) BURN). HOWEVER, THERE WAS NO REPORT OF ANY HEALTH CARE PROFESSIONAL CONSULT NOR ANY TREATMENT DETAILS REPORTED. CASE ASSESSED AS SERIOUS INJURY AS THE CONSUMER LABELED ¿TYPE OF EVENT¿ AS SERIOUS INJURY. THEREFORE, CASE WAS PROCESSED IN ALIGNMENT WITH RECEIPT OF VOLUNTARY MEDWATCH REPORT (MW5180287) AND CODED WITH HEALTH EFFECT IMPACT CODE OF SERIOUS INJURY/ILLNESS/IMPAIRMENT TO REFLECT THAT INFORMATION. WILL REASSESS IF ANY ADDITIONAL DETAILS ABOUT PRODUCT USAGE AND DURATION OF USE, EVENTS ATTRIBUTED TO PRODUCT USE, TREATMENT TAKEN, HEALTH CARE PROFESSIONAL CONSULT, DIAGNOSIS IF ANY, EVENT OUTCOME, UNDERLYING MEDICAL HISTORY AND CONCOMITANTS BECOME AVAILABLE. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH AND TWO VOLUNTARY MEDWATCHES WERE RECEIVED FOR THIS PATIENT. SEE MW5180287 & MW5180374. 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 SERIOUS INJURY EVENT WAS REPORTED VIA VOLUNTARY MW5180287 FOR BAND-AID BRAND TRU-STAY SHEER BANDAGE. A 49-YEAR-OLD FEMALE CONSUMER REPORTED THAT SHE ¿APPLIED A BAND-AID TO PROTECT A LESION ON STOMACH AND HAVE A BURN ON SKIN¿. THE CONSUMER ALSO REPORTED THAT SHE HAD SUSTAINED CHEMICAL BURNS ON SKIN. NO FURTHER INFORMATION WAS PROVIDED. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH & 2214133-2026-00001. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH AND TWO VOLUNTARY MEDWATCHES WERE RECEIVED FOR THIS PATIENT. SEE MW5180287 & MW5180374.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61341 BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER TAPE AND BANDAGE, ADHESIVE KGX KENVUE BRANDS, LLC 381370046691 1265B

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other ATORVASTATIN| LEVOTHYROXINE| LOSARTAN| METFORMIN