BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB FLEXIBLE FABRIC BANDAGES

    MDR report key: 21331907 · Received February 7, 2025

    Report

    Report Number
    1000599868-2025-00001
    Event Type
    Injury
    Date Received
    February 7, 2025
    Report Date
    February 14, 2025
    Manufacturer
    KENVUE BRANDS, LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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¿ 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. A2, A4, A5, A6: AGE, WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR BAB FLEXIBLE FABRIC ASSORTED 100 CT USA 381371150786 8137115078USA,LOT# 200827. D4: 510(K) EXEMPT DEVICE I COMPLAINT, UDI NOT REQUIRED: (B)(4). UPC = 381371150786, LOT NUMBER = 200827, EXPIRATION DATE= NA. D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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: HEALTH EFFECT CLINICAL CODE: E0402 - REFERS TO CONSUMER ALLEGED ALLERGIC REACTION (SKIN HIVES, ITCHING). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H4, H6: 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 AUGUST 27, 2020. RAW MATERIAL AND COMPONENT RECORDS WERE REVIEWED AND WERE FOUND ACCEPTABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #2 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. CORRECTION: B4: DATE OF THIS REPORT IS CORRECTED FROM 02 FEB 2025 TO 07 FEB 2025. DATE RECEIVED BY MANUFACTURER REMAINS 20 JAN 2025. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW- UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    A FEMALE CONSUMER REPORTED AN ALLERGIC REACTION (SKIN HIVES AND ITCHING) WITHIN 2 HOURS AFTER USING FLEXIBLE FABRIC BANDAGE TO COVER A CUT. THE CONSUMER SOUGHT MEDICAL ATTENTION FROM A HEALTH CARE PROFESSIONAL AND CONSULTATION WAS REPORTED TO STOP USING THE PRODUCT AND AN UNSPECIFIED STEROID CREAM WAS PRESCRIBED TO TREAT THE EVENT. SYMPTOMS WERE IMPROVED AFTER CONSUMER STOPPED USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623913 BAB FLEXIBLE FABRIC BANDAGES TAPE AND BANDAGE, ADHESIVE KGX KENVUE BRANDS, LLC 381371150786 200827

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention