BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEROYAL

    MDR report key: 1649770 · Received March 30, 2010

    Report

    Report Number
    MW5015376
    Event Type
    Injury
    Date Received
    March 30, 2010
    Date of Event
    March 11, 2010
    Report Date
    March 30, 2010
    Manufacturer
    DEROYAL
    Product Code
    FCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS NO PT INVOLVEMENT WITH THIS DEFECTIVE ITEM. THE HI-FLOW INSUFFLATION TUBING WAS PRE STERILIZED IN THE LAPAROSCOPY PACK. THE FLOW WOULD NOT WORK THROUGH THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL INSUFLATION TUBING FCX DEROYAL 28-0213NS 002205B

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability