BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTERIOR HIP PACK

    MDR report key: 6961099 · Received October 19, 2017

    Report

    Report Number
    6961099
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Date of Event
    October 2, 2017
    Report Date
    October 10, 2017
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STERILITY OF ANTERIOR HIP SURGICAL PACK QUESTIONED AND CONSIDERED CONTAMINATED DUE TO WOOD FOUND WITHIN LAP SPONGES LOCATED WITHIN THE STERILE SURGICAL PACK. SURGERY CANCELLED BY SURGEON LATE IN DAY. OUTCOME: 1. DELAY OF CONSUMER SERVICE ISSUE, FOR PATIENT, PATIENT'S FAMILY, AND PHYSICIAN. 2. COST ISSUE: ALL SUPPLIES HAD TO BE WASTED AND ALL INSTRUMENTATION HAD TO BE REPROCESSED / RESTERILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740349 ANTERIOR HIP PACK GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS CDMH06C-01 867171

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR NOT APPLICABLE.