BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMC LAPAROTOMY PACK

    MDR report key: 7822176 · Received August 28, 2018

    Report

    Report Number
    7822176
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    August 10, 2018
    Report Date
    August 15, 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

    ROOM SET UP, ABOUT TO MAKE INCISION, HAIR FOUND IN LAP SPONGE. SETUP WAS TORN DOWN, CASE RE-PICKED AND RE-OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664134 CMC LAPAROTOMY PACK GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS 809181

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA