BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI ARC

    MDR report key: 1213587 · Received October 27, 2008

    Report

    Report Number
    MW5008791
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    May 5, 2008
    Report Date
    October 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT A MINIARC PUBOVAGINAL SLING -BOSTON SCIENTIFIC- FOR TREATMENT OF SUI BY ANOTHER PROVIDER, AND HAD EXPOSED MESH FIBERS VAGINALLY POSTOP. THIS REQUIRED RESECTION OF THE EXPOSED FIBERS AS AN OUTPATIENT, AND PROBLEM IS RESOLVED. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: STRESS URINARY INCONTINENCE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI ARC SYNTHETIC MID URETHRAL SLING FTL BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Disability