BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPARC SLING SYSTEM

    MDR report key: 3954898 · Received July 24, 2014

    Report

    Report Number
    2183959-2014-00318
    Event Type
    Injury
    Date Received
    July 24, 2014
    Report Date
    June 30, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RELATED TO MFR REPORT NUMBERS: 2183959-2014-00317 AND 2183959- 2014-00316. IT WAS REPORTED THAT DURING THE ATTEMPT TO IMPLANT A SPARC SLING SYSTEM THE TROCAR OF THE SPARC WAS PLACED INTO THE BLADDER NECK; THE OPERATION WAS ABORTED AND THE BLADDER NECK REPAIRED. THE PATIENT LATER SAW ANOTHER DOCTOR AND A NON-AMS RETROPUBIC SLING WAS IMPLANTED AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435341 AMS SPARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ELEVATE| MINIARC