BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND-AID® BRAND AHESIVE BANDAGES FLEXIBLE FABRIC

    MDR report key: 7654874 · Received July 2, 2018

    Report

    Report Number
    8041154-2018-00007
    Event Type
    Injury
    Date Received
    July 2, 2018
    Date of Event
    June 1, 2018
    Report Date
    July 3, 2018
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE MANUFACTURE DATE: 12/13/2017. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS FOLLOW-UP MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CONSUMER PURCHASED THE PRODUCT IN THE UNITED STATES BUT IS A RESIDENT OF (B)(6). (B)(4). LOT NUMBER = (10)3477. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. (B)(4). 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 · 1

    A (B)(6) FEMALE CONSUMER ALLEGES THAT ON (B)(6) 2018 THE FLEXIBLE FABRIC BAND-AID CAUSED AN INFECTION ON ONE OF HER BREASTS. BLISTERS APPEARED UNDER THE ADHESIVE PART OF THE BANDAGE AND THEN THE BLISTERS GOT INFECTED. CONSUMER WAS TREATED FOR THE INFECTION BY A PHYSICIAN WHO PRESCRIBED CEPHALEXIN 500 MG FOUR TIMES A DAY. AT THE TIME OF THIS REPORT, CONSUMER HAS NOT RECOVERED FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497906 BAND-AID® BRAND AHESIVE BANDAGES FLEXIBLE FABRIC ADHESIVE BANDAGE KGX JOHNSON & JOHNSON CONSUMER INC 381370044307 3477B

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention POLYSPORIN| POLYSPORIN