BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS RETROARC RETROPUBIC SLING SYSTEM

    MDR report key: 3891162 · Received June 24, 2014

    Report

    Report Number
    2183959-2014-00241
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN AMS RETROARC SLING IMPLANTED (B)(6) 2014. IT WAS INDICATED THAT FOLLOWING THIS IMPLANT THE PATIENT EXPERIENCED RETENTION. ON (B)(6) 2014 THE SLING WAS REVISED, "BY CUTTING OR PULLING TAPE SLIGHTLY AT LATERAL PORTION." IT WAS REPORTED THAT THE PATIENT IS DOING WELL AND VOIDING APPROPRIATELY FOLLOWING THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368188 AMS RETROARC RETROPUBIC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R