BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOARC SLING SYSTEM

    MDR report key: 3140899 · Received May 24, 2013

    Report

    Report Number
    2183959-2013-00848
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH A BIOARC SLING TO TREAT HER INCONTINENCE ON (B)(6) 2012. THE PATIENT'S INCONTINENCE ORIGINALLY IMPROVED. THEN THE PATIENT'S INCONTINENCE ORIGINALLY IMPROVED. THEN THE DEVICE APPEARED TO "STOP WORKING" AND HER INCONTINENCE RETURNED. THE PATIENT WAS THEN IMPLANTED WITH A MONARC SLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232368 BIOARC SLING SYSTEM SURGICAL MESH OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R