BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND PRO HEAL ADHESIVE BANDAGES

    MDR report key: 22412311 · Received July 7, 2025

    Report

    Report Number
    8041154-2025-00006
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    June 16, 2025
    Report Date
    July 7, 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 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 (B)(6). ITS PREVIOUS CORPORATE HEADQUARTERS WAS (B)(6). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A4, A5, A6: PATIENT WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) BANDAID PRO HEAL ASSORTED 15CT USA (B)(4), LOT # 1244B. D4: 510(K) EXEMPT, DEVICE I COMPLAINT. UDI NOT REQUIRED. UDI # (B)(4). UPC # 381372024055 LOT # 1244B EXPIRATION DATE: NA. D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 MAY 03, 2024. H6: E171601 REFERS TO THE CONSUMER ALLEGED " IT LEFT A PAINFUL RED AREA IN THE SHAPE OF THE BANDAGE (REDNESS) & QUOT;. E2330 REFERS TO THE CONSUMER ALLEGED " IT LEFT A PAINFUL RED AREA IN THE SHAPE OF THE BANDAGE (PAIN) & QUOT;. E040203 REFERS TO THE CONSUMER ALLEGED " THE SKIN IS SHINY¿. E1703 REFERS TO THE CONSUMER ALLEGED ¿THE SKIN IS BLISTERING¿. E1708 REFERS TO THE CONSUMER ALLEGED ¿THE SKIN IS ITCHING¿. 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 FEMALE CONSUMER REPORTED USING ONE BAND-AID PRO HEAL BANDAGE ON (B)(6) 2025 TO COVER A SMALL CUT ON HER ARM. UPON THE BANDAGE REMOVAL ON THE SAME DAY, IT LEFT A PAINFUL RED AREA IN THE SHAPE OF THE BANDAGE. THE SKIN WAS SHINY AND BLISTERING ALONG WITH BEING ITCHY AND PAINFUL. IT WAS REPORTED THAT THE CONSUMER VISITED A HEALTHCARE PROVIDER AND WAS PRESCRIBED WITH ANTIBIOTIC DOXYCYCLINE HYCLATE 100 MG. THE CONSUMER STOPPED USING THE PRODUCT AND HER SYMPTOMS HAVE IMPROVED AT THE TIME OF THIS REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2768163 BAND AID BRAND PRO HEAL ADHESIVE BANDAGES TAPE AND BANDAGE, ADHESIVE KGX KENVUE BRANDS, LLC 381372024055 1244B

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention