BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND TRU STAY CLEAR BANDAGES

    MDR report key: 23729639 · Received December 5, 2025

    Report

    Report Number
    8041154-2025-00014
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    November 6, 2025
    Report Date
    December 5, 2025
    Manufacturer
    KENVUE BRANDS, LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 & 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. D1, D2, D3, D4; THIS REPORT IS FOR ONE (1) BAND AID BRAND TRU STAY CLEAR SPOT BANDAGES 50CT USA 381370047087 381370047087USA, LOT #1724B D4: 510(K) EXEMPT, DEVICE I COMPLAINT. UDI NOT REQUIRED. UDI # ((B)(4), UPC # 381370047087, LOT # 1724B. D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H4, H6: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED. THERE WERE NO PROCESSING OR PACKAGING DEVIATIONS ASSOCIATED WITH THIS BATCH. RAW MATERIAL AND COMPONENT RECORDS WERE REVIEWED FOR THIS LOT. ALL RAW MATERIALS PASSED THE INCOMING QUALITY INSPECTION WITH NO ISSUES SEEN. THERE WERE NO CHANGES TO ANY RAW MATERIALS USED FOR THIS LOT. ALL COMPONENTS ALSO PASSED THE INCOMING QUALITY INSPECTION WITH NO ISSUES SEEN. THE PRODUCT WAS MANUFACTURED ON JUNE 21, 2024. H6: E171601- REFERS TO THE CONSUMER ALLEGED "PRODUCT BURNED HIS FACE". CASE IS BEING REPORTED AS AN OVER ABUNDANCE OF CAUTION GIVEN THE EMERGENCY RO0M INFORMATION. CONSUMER REPORTED THAT THE PRODUCT ADHESIVE BURNED HIS FACE; HE APPLIED ¿ANTIBIOTIC OINTMENT¿ AND ALSO WENT TO ER AND WAS GIVEN UNSPECIFIED ¿PAIN MEDICATION¿ (ROUTE NOT SPECIFIED; INTERPRETED AS ORAL/TOPICAL) FOR ¿PAIN¿; BASED ON OVERALL DETAILS AVAILABLE, EVENT INTERPRETED AS APPLICATION SITE BURN (SUBSUMED PAIN), NO DIRECT REPORT OF ALLERGIC REACTION IN AVAILABLE INFORMATION THUS IT WAS NOT CONSIDERED. NO IME, NO HOSPITALIZATION, NO SIGNIFICANT INTERVENTION REPORTED AND NO OTHER SERIOUSNESS CRITERIA MET. CASE WILL BE REVIEWED IF RECEIPT OF ADDITIONAL DETAILS ABOUT PRODUCT USAGE AND DURATION OF USE, EVENTS ATTRIBUTED TO PRODUCT USE, TREATMENT RECEIVED IN ER, INVESTIGATIONS DONE, HCP DIAGNOSIS IF ANY, EVENT OUTCOME, UNDERLYING MEDICAL HISTORY AND CONCOMITANTS IF ANY IS PROVIDED. 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 MALE CONSUMER REPORTED AN ADVERSE EVENT WITH BAND AID BRAND TRU STAY CLEAR SPOT BANDAGE. IT WAS REPORTED THAT THE PRODUCT ADHESIVE BURNED HIS FACE ON (B)(6) 2025. THE PRODUCT WAS APPLIED TO COVER A CUT ON HIS FACE ON THE SAME DAY. IT WAS REPORTED THAT THE CONSUMER APPLIED ANTIBIOTIC OINTMENT AND ALSO WENT TO ER ON (B)(6) 2025 FOR RELATED SYMPTOMS. THE CONSUMER WAS GIVEN UNSPECIFIED PAIN MEDICATION FOR PAIN. THE CONSUMER ALLEGED THAT THE SYMPTOMS HAVE STAYED THE SAME AFTER STOPPING USE OF THE PRODUCT. NO HOSPITALIZATION AND NO SIGNIFICANT INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043271 BAND AID BRAND TRU STAY CLEAR BANDAGES TAPE AND BANDAGE, ADHESIVE KGX KENVUE BRANDS, LLC 381370047087 1724B

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Required Intervention