BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPARC SLING SYSTEM

    MDR report key: 3902643 · Received June 30, 2014

    Report

    Report Number
    2183959-2014-00255
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 3, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD DIFFICULTY VOIDING AFTER THE SPARC SLING WAS IMPLANTED. THE PATIENT ALSO HAD A GRAFT IMPLANTED AT THE SAME TIME, THE PHYSICIAN FELT THE DIFFICULTY VOIDING IS DUE TO THE SLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380618 AMS SPARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ELEVATE ANTERIOR