BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB FLEXIBLE FABRIC BANDAGES

    MDR report key: 24764221 · Received April 2, 2026

    Report

    Report Number
    8041154-2026-00008
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    March 15, 2026
    Report Date
    April 2, 2026
    Manufacturer
    KENVUE BRANDS, LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 (B)(6) NJ 08558. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A3, A4, A5 AND A6: PATIENT SEX, WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) BAND AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC ALL ONE SIZE 30CT USA (B)(4) USA, LOT NUMBER 0515B. D4: 510(K) EXEMPT DEVICE I COMPLAINT. UDI IS NA FOR THIS SUBMISSION. UDI: (B)(4). UPC #381370044314 EXPIRATION DATE: NA LOT #0515B D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION AND PRODUCT WAS MANUFACTURED PER SPECIFICATION. THE PRODUCT WAS MANUFACTURED ON FEBRUARY 20, 2025 H6: E1714 - CONSUMER ALLEGED MILD RASH WHERE THE ADHESIVE MADE SKIN CONTACT. E2402 - CONSUMER MISUSE/OFF-LABEL USE - INTENTIONAL. THE CONSUMER USED THE PRODUCT FOR A SCRAPE BIOPSY AND REPORTED EXPERIENCING A MILD RASH WHERE THE ADHESIVE MADE SKIN CONTACT. CONSUMER CONTACT HCP AND THE EVENT WAS TREATED WITH CORTISONE (ROUTE NOT SPECIFIED; INTERPRETED AS ORAL/TOPICAL). BASED ON AVAILABLE INFORMATION, NO IME, NO HOSPITALIZATION, NO SIGNIFICANT INTERVENTION REPORTED AND NO OTHER SERIOUSNESS CRITERIA MET. IF ADDITIONAL 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 58-YEAR-OLD CONSUMER USED BAND AID BRAND ADHESIVE BANDAGE FLEXIBLE FABRIC BAND-AID ON A SCRAPE BIOPSY AND REPORTED EXPERIENCING A MILD RASH WHERE THE ADHESIVE MADE SKIN CONTACT. CONSUMER SOUGHT MEDICAL INTERVENTION WITH HEALTH CARE PROFESSIONAL AND WAS TREATED WITH CORTISONE FOR THIS MEDICAL EVENT. IT WAS REPORTED THAT THE CONSUMER'S SYMPTOMS HAVE COMPLETELY RESOLVED AFTER CONSUMER STOPPED USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825215 BAB FLEXIBLE FABRIC BANDAGES TAPE AND BANDAGE, ADHESIVE KGX KENVUE BRANDS, LLC 381370044314 0515B

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Required Intervention