BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL - BLUE U-DRAPE IN HAND/ELBOW PACK

    MDR report key: 4929774 · Received July 9, 2015

    Report

    Report Number
    4929774
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 26, 2015
    Report Date
    July 9, 2015
    Product Code
    KKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A BLUE U-DRAPE WAS USED FOR PROXIMAL ROW CARPECTOMY, EXCISION OF SYNOVIAL CYST, REPAIR OF FLEXOR CARPI ULNARIS TENDON ON (B)(6) 2015. DURING REMOVAL OF THE SURGICAL DRAPE, A LARGE SKIN TEAR WAS NOTED ON THE PROXIMAL FOREARM, APPROXIMATELY 8 CM X 10 CM. THE LARGE SKIN AVULSION IS SUSPECTED TO BE SECONDARY TO THE UNUSUALLY ADHESIVE PLASTIC DRAPES THAT WERE USED TO ISOLATE THE OPERATIVE SITE. PLASTIC FOREIGN BODY WAS CAREFULLY REMOVED FROM THE FOREARM. AREA DEBRIDED, SUTURED. SILVADENE CREAM AND DRESSING APPLIED. DEBRIDEMENT AND SPLIT-THICKNESS SKIN GRAFT PERFORMED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444706 CARDINAL - BLUE U-DRAPE IN HAND/ELBOW PACK CARDINAL - BLUE U-DRAPE IN HAND/ELBOW PACK KKX 362463

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention