BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM GYNECOLOGY PACK

    MDR report key: 7845436 · Received September 5, 2018

    Report

    Report Number
    7845436
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Date of Event
    August 8, 2018
    Report Date
    August 23, 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

    CMC GYN MAJOR PACK LOT #807181 ONLY CONTAINED 9 RAYTEC. THE WHITE PAPER STRAP WAS AROUND THEM AND REMOVED FOR COUNTING. THE PACK ONLY CONTAINED 9 RAYTEC. THEY WERE GATHERED UP AND REMOVED FROM THE ROOM. MANAGER AND CHARGE NURSE NOTIFIED. INDIVIDUAL STERILE PACK OF RAYTEC OPENED, COUNTED, AND USED FOR CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686940 CUSTOM GYNECOLOGY PACK GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS CDGM11D 807181

    Patients

    Seq Age Sex Outcome Treatment
    1 25550 DA