BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX

    MDR report key: 19729761 · Received July 12, 2024

    Report

    Report Number
    2214133-2024-00029
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    June 14, 2024
    Report Date
    June 20, 2024
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    NAD
    UDI-DI
    381371183494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    JOHNSON & JOHNSON CONSUMER, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH JOHNSON & JOHNSON CONSUMER, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, JOHNSON & JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, JOHNSON & JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT FOR DIAGNOSIS. A4, A5: WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) (BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX EXTRA LARGE 7CT USA 381371183494 381371183494USA, LOT/CTRL # 0224B). D4: UPC #: 381371183494 LOT #: 0224B EXP DATE: NA UDI #: (B)(4). D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H6: HEALTH EFFECT CLINICAL CODE E1719 REFERS TO "RASH/IRRITATION". E2339 REFERS TO "SORE AND TORN SKIN¿. E2402 REFERS TO CONSUMER "INTENTIONAL MISUSE/OFF-LABEL USE" OF THE PRODUCT. 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 JANUARY 22, 2024. RAW MATERIAL AND COMPONENT RECORDS WERE REVIEWED AND WERE FOUND ACCEPTABLE. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2024-00028. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS INITIAL BAB (01) MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A 57 YEAR OLD FEMALE CONSUMER STARTED TO USE BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX EXTRA LARGE TO KEEP AN INCISION COVERED AND PROTECTED FROM A SURGICAL INCISION. THE CONSUMER USED PRODUCT TWICE. ON (B)(6) 2024, THE CONSUMER BROKE OUT INTO A BAD RASH AND HAD TO GO TO THE EMERGENCY ROOM. IT¿S REPORTED THE CONSUMER WAS TREATED WITH ORAL BENADRYL AND TOPICAL TRIAMCINOLONE ACETONIDE PRESCRIBED BY DERMATOLOGIST FOR SKIN RASH. THE CONSUMER HAD SORES AND TORN SKIN. THE SYMPTOMS HAVE STAYED THE SAME AFTER THE CONSUMER STOPPED USING THE PRODUCT. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2024-00028. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2349070 BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX DRESSING, WOUND, OCCLUSIVE NAD JOHNSON & JOHNSON CONSUMER INC 381371183494 0224B 381371183494

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention