BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS RETROARC RETROPUBIC SLING SYSTEM

    MDR report key: 4221022 · Received November 3, 2014

    Report

    Report Number
    2183959-2014-00485
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 10, 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 THAT A RETROARC RETROPUBIC SLING PATIENT HAD A "BLADDER PERFORATION WITHOUT INCIDENT" DURING THE IMPLANT OF HER SLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702239 AMS RETROARC RETROPUBIC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention