BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB FLEXIBLE FABRIC BANDAGES

    MDR report key: 21739762 · Received April 1, 2025

    Report

    Report Number
    1000599868-2025-00004
    Event Type
    Injury
    Date Received
    April 1, 2025
    Date of Event
    March 3, 2025
    Report Date
    April 1, 2025
    Manufacturer
    KENVUE BRANDS, LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 (B)(6) 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 (B)(6) 2024. KENVUE RECENTLY MOVED TO ITS NEW CORPORATE HEADQUARTERS IN (B)(6) NJ. ITS PREVIOUS CORPORATE HEADQUARTERS WAS (B)(6). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A4, A5, A6: PATIENT WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (BAB FLEXIBLE FABRIC ASSORTED 100 CT USA (B)(4), LOT NUMBER # 221104). D4: 510(K) EXEMPT DEVICE I COMPLAINT. UDI: (B)(4) UPC #: 381371150786 EXPIRATION DATE: NA LOT # 221104 D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H4, H6: A BATCH RECORD REVIEW WAS COMPLETED WITH NO ANOMALIES FOUND. ALL PACKAGED PRODUCT MET ALL ESTABLISHED ANALYTICAL AND MICROBIOLOGICAL PARAMETERS. THERE WERE NO PROCESSING OR PACKAGING DEVIATIONS ASSOCIATED WITH THIS BATCH. RAW MATERIAL RECORDS WERE REVIEWED FOR THIS LOT. ALL RAW MATERIALS PASSED THE INCOMING QUALITY INSPECTION WITH NO ISSUES SEEN. ALL FINISHED PRODUCTS WERE TESTED IN ACCORDANCE WITH SPECIFICATION AT THE RELEASE TIME AND ALL THE TESTS RESULTS MET SPECIFICATIONS. THE PRODUCT WAS MANUFACTURED ON (B)(6) 2022. H6: E0402 ALSO REFERS TO THE CONSUMER ALLEGED FOR (ALLERGY TO THE FLEXIBLE BANDS AND GETTING WORSE (SUBSUMED ITCHING). E2402 REFERS TO CONSUMER " INTENTIONAL MISUSE/OFF-LABEL USE" OF THE PRODUCT. THE PRODUCT WAS USED FOR A ¿SMALL BURN ON ARM¿ FOLLOWING WHICH THE CONSUMER DEVELOPED ALLERGY (SUBSUMED ITCHY). THE CONSUMER USED ¿BENADRYL CREAM FOR THE ITCH¿ AND ¿HYDROCORTISONE¿ (ROUTE INTERPRETED AS ORAL/TOPICAL) TO TREAT THE EVENTS AND ALSO CONSULTED HCP WHO RECOMMENDED UNSPECIFIED TREATMENT, ¿ONE FOR INFECTION AND ONE FOR THAT IT¿, NO FURTHER DETAILS REPORTED. NO HOSPITALIZATION, NO SIGNIFICANT INTERVENTION REPORTED. 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 62-YEAR FEMALE CONSUMER REPORTED AN EVENT WITH BAND AID BRAND FLEXIBLE FABRIC BANDAGE. CONSUMER USED PRODUCT ON (B)(6)2025 TO COVER SMALL BURN ON ARM. ON THE SAME DAY ((B)(6)2025), CONSUMER DEVELOPED AN ALLERGIC REACTION (ITCHING) AND SKIN INFECTION. CONSUMER SOUGHT MEDICAL INTERVENTION AND TREATED THE EVENT WITH BENADRYL CREAM AND HYDROCORTISONE. THE SPECIFIC TREATMENT/PRESCRIPTION RECOMMENDED BY THE HEALTH CARE PROFESSIONAL WAS NOT PROVIDED. CONSUMER REPORTED HER SYMPTOMS HAVE WORSENED AFTER PRODUCT WAS LAST USED. THERE IS NO ADDITIONAL INFORMATION WITH REGARDS TO EVENT AND OUTCOME FOR THIS CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932887 BAB FLEXIBLE FABRIC BANDAGES TAPE AND BANDAGE, ADHESIVE KGX KENVUE BRANDS, LLC 381371150786 221104

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention