BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND BREATHABLE BANDAGES

    MDR report key: 20457606 · Received October 15, 2024

    Report

    Report Number
    1000599868-2024-00005
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    May 21, 2024
    Report Date
    October 24, 2024
    Manufacturer
    KENVUE
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A1, A3B, A4, A5: PATIENT ID, GENDER, WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR (BAND AID BRAND BREATHABLE BANDAGES (B)(4)). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAB SHEER 1INX3IN (B)(4)), LOT#220903. D4: 510(K) EXEMPT DEVICE I COMPLAINT: UDI NOT REQUIRED: (B)(4). UPC = 916999000713. EXPIRATION DATE= 250831. LOT NUMBER = 220903. D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED AT THIS TIME; 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 ALSO REFERS TO CONSUMER ALLEGED ABOUT " ALLERGIC (SUBSUMED PRURITUS). 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. H2, 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 SEP-03-2022. 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

    IT WAS REPORTED THAT A CONSUMER WENT TO A HOSPITAL IN CHINA TO BUY A BREATHABLE BANDAGE DUE TO A FINGER INJURY. THE CONSUMER DEVELOPED PRURITUS AT THE FINGER FITTING SITE OF FINGERS ABOUT 2 HOURS AFTER APPLYING THE BANDAGE TO THE WOUND. AFTER CONSULTING WITH THE A HEALTH CARE PROFESSIONAL, THE CONSUMER WIPED THE AFFECTED SITE WITH ETHYL ALCOHOL AND THEN APPLIED A PRESCRIPTION OF MOMETASONE FUROATE CREAM TO THE ALLERGIC SITE. HALF AN HOUR LATER, THE PATIENT WAS RECOVERING WITHOUT PRURITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2567910 BAND AID BRAND BREATHABLE BANDAGES TAPE AND BANDAGE, ADHESIVE KGX KENVUE 6916999000713 220903

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention