BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPARC SLING SYSTEM

    MDR report key: 3902872 · Received June 30, 2014

    Report

    Report Number
    2183959-2014-00257
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPARC IMPLANTATION PROCEDURE WHICH RESULTED IN A PROLONGED SURGERY TIME AND THE PASSING OF TWO ADDITIONAL NEEDLES TO IMPLANT ANOTHER SLING. IT WAS INDICATED THAT THE PHYSICIAN PASSED THE SLING NEEDLES AND PERFORMED A CYSTOSCOPY. THE SLING WAS THEN CONNECTED TO THE TROCARS AND THE SLING WAS PULLED IN PLACE SUBURETHRALLY. UPON PLACING HEMOSTATS ON THE PLASTIC SHEATHS, THE PHYSICIAN WAS UNABLE TO REMOVE THE SHEATHS. THE PLASTIC TORE AND THE SHEATH WOULD NOT RELEASE. THE PHYSICIAN REMOVED THE SLING AND IMPLANTED ANOTHER SLING. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379367 AMS SPARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R