BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC

    MDR report key: 1081177 · Received July 11, 2008

    Report

    Report Number
    1081177
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    June 9, 2008
    Report Date
    July 11, 2008
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PIECE OF EQUIPMENT THAT WAS USED TO IMPLANT A PUBO-VAGINAL SLING BROKE OFF INSIDE THE PATIENT, WHILE THE DOCTOR WAS INSERTING THE PIECE UP AROUND THE RAMUS. THE DOCTOR INDICATED THAT A PIECE OF PLASTIC CAME OFF THE INSTRUMENT, WHICH WAS ATTACHED TO THE SLING ITSELF. THE PIECE WAS SMALL AND WAS ULTIMATELY LEFT INSIDE THE PATIENT, SINCE IT WILL NOT CAUSE THE PATIENT ANY HARM AND ULTIMATELY A MORE INVASIVE SURGERY WOULD HAVE BEEN REQUIRED TO RETRIEVE THE PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARC SLING, UROLOGY FTL AMERICAN MEDICAL SYSTEMS, INC. * 542431053

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention