BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB FLEXIBLE FABRIC BANDAGES

    MDR report key: 22938127 · Received September 2, 2025

    Report

    Report Number
    1000599868-2025-00007
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    August 3, 2025
    Report Date
    September 2, 2025
    Manufacturer
    KENVUE BRANDS, LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 ADHESIVE BANDAGES FLEXIBLE FABRIC STRIPS 10CT USA (B)(4), LOT #240613. D4: 510(K) EXEMPT, DEVICE I COMPLAINT. UDI NOT REQUIRED. UDI # (B)(4). UPC # 381370056850. LOT # 240613. EXPIRATION DATE: NA. 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 JUNE 13, 2024. H6: E0402 ALSO REFERS TO THE CONSUMER ALLEGED " ALLERGIC TO THE ADHESIVE, BROKE OUT IN A TERRIBLE RASH". CONSUMER REPORTED THAT HE ¿MUST BE ALLERGIC TO THE ADHESIVE¿ AND THAT HE ¿BROKE OUT IN A TERRIBLE RASH¿ (EVENT INTERPRETED AS APPLICATION SITE ALLERGY, SUBSUMED RASH). HCP WAS CONSULTED WHO ADVISED TO ¿APPLY VASELINE TO AFFECTED AREA COVER WITH NON-STICK DRESSING WRAP WITH ACE SO COVERING DOES NOT MOVE¿. IT WAS ALSO REPORTED THAT THE HCP RECOMMENDED TO TAKE AN UNSPECIFIED ANTIBIOTIC (ROUTE INTERPRETED AS ORAL) ¿SO AN INFECTION DOES NOT SPREAD TO KNEES¿ WHICH WAS INTERPRETED TO BE PROPHYLACTIC AND PRECAUTIONARY, NO CONFIRMED REPORT OF ANY INFECTION IN AVAILABLE INFORMATION. NO HOSPITALIZATION, NO SIGNIFICANT INTERVENTION REPORTED AND NO OTHER SERIOUSNESS 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 64-YEAR MALE CONSUMER REPORTED AN EVENT WITH BAND AID BRAND ADHESIVE BANDAGE FLEXIBLE FABRIC STRIP WHICH HE USED FOR AN INJURY CUT. CONSUMER REPORTED THAT HE EXPERIENCED AN ALLERGIC REACTION TO THE ADHESIVE; BROKE OUT IN A TERRIBLE RASH. CONSUMER ALSO REPORTED THAT HE CONSULTED A HEALTH CARE PROFESSIONAL (HCP) AND WAS INSTRUCTED TO APPLY VASELINE TO AFFECTED AREA, COVER WITH NON-STICK DRESSING WRAP WITH ACE SO COVERING DOES NOT MOVE AND AN UNSPECIFIED PROPHYLACTIC ANTIBIOTIC TO PREVENT INFECTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240646 BAB FLEXIBLE FABRIC BANDAGES TAPE AND BANDAGE, ADHESIVE KGX KENVUE BRANDS, LLC 381370056850 240613

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention