BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOARTS

    MDR report key: 3845891 · Received May 29, 2014

    Report

    Report Number
    MW5036405
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 27, 2014
    Manufacturer
    KIMBERLY-CLARK
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TOTAL HIP DRAPE HAD A DEFECTIVE "POCKET". THE ADHESIVE GLUE THAT KEEPS THE "POCKET" TOGETHER IS INSUFFICIENT, POTENTIALLY ALLOWING STERILE SUPPLIES TO BECOME CONTAMINATED WITHOUT KNOWLEDGE OF SURGICAL STAFF. OCCURRED DURING A LEFT HIP HEMIARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317448 ORTHOARTS HIP DRAPE KKX KIMBERLY-CLARK REF 89345 CA31442

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR