BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IVS TUNNELLER DEVICE

    MDR report key: 3082910 · Received April 22, 2013

    Report

    Report Number
    6000141-2013-00041
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BALLYMONEY - USS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171469 UNKNOWN IVS TUNNELLER DEVICE IVS TUNNELLER FTL BALLYMONEY - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other