BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE TRANSOBTURATOR SLING

    MDR report key: 2802979 · Received October 16, 2012

    Report

    Report Number
    1645337-2012-00220
    Event Type
    Injury
    Date Received
    October 16, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A CORRECTION OF THE MFR REPORT NUMBER ON THE FIRST PAGE. ORIGINALLY REPORTED AS 1645337-2012-002120 BUT THE CORRECT NUMBER IS 1645337-2012-00220.

    Description of Event or Problem · 1

    PT EXPERIENCED EROSION, INFECTION AND PAIN. NO OTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTAPE TRANSOBTURATOR SLING TRANSOBTURATOR FTL MENTOR WORLDWIDE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other