BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOMA SCREWS

    MDR report key: 2875397 · Received December 11, 2012

    Report

    Report Number
    MW5028074
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    November 15, 2012
    Report Date
    December 3, 2012
    Manufacturer
    INTEGRA-JARET INSTRUMENTS
    Product Code
    HHO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CORKSCREW END OF LAPAROSCOPIC INSTRUMENT BROKE FREE IN UTERUS INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYOMA SCREWS NONE HHO INTEGRA-JARET INSTRUMENTS 615-210 54557

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention