BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMC EXTREMITY PACK

    MDR report key: 7822082 · Received August 28, 2018

    Report

    Report Number
    7822082
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    August 17, 2018
    Report Date
    August 20, 2018
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE HAD OPENED THE SURGICAL PACK AND THE SCRUB WAS SETTING UP AND AT THE BOTTOM OF THE PACK THERE WAS A PLASTIC BAG THAT YOU PEEL THE TOP OFF AND STICK ON THE SIDE OF YOUR TABLE. THE SCRUB NOTICED A BUG IN BETWEEN THE STICKY PART AND THE PEEL OFF STRIP. WE TORE DOWN THE SETUP AND STARTED OVER AND RE-PICKED THE CASE FOR NEW SET UP. THE PATIENT NEVER CAME IN THE ROOM UNTIL SECOND SETUP WAS ACCOMPLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665785 CMC EXTREMITY PACK GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS 807181

    Patients

    Seq Age Sex Outcome Treatment
    1 19710 DA