BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOMA SCREW

    MDR report key: 1738054 · Received June 24, 2010

    Report

    Report Number
    MW5016494
    Event Type
    Injury
    Date Received
    June 24, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 17, 2010
    Manufacturer
    JARIT/INTEGRA
    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

    DURING A LAPAROSCOPIC SUPRA-CERVICAL HYSTERECTOMY, THE END OF MYOMA SCREW FRACTURED OFF AND SMALL INCISION WAS MADE TO REMOVE IT. IT WAS LODGED IN THE SUBCUTANEOUS TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYOMA SCREW NONE HHO JARIT/INTEGRA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention