BEUDAMED
    FDA Adverse Event Other Summary report: N

    UROGYN

    MDR report key: 3432819 · Received September 30, 2013

    Report

    Report Number
    1835241-2013-00001
    Event Type
    Other
    Date Received
    September 30, 2013
    Date of Event
    August 21, 2013
    Report Date
    September 27, 2013
    Manufacturer
    OMNITECH SYSTEMS, INC.
    Product Code
    KNF
    PMA / PMN Number
    K981464
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LOOP ATTACHED DURING EVACAUATION OF BLADDER CLOT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492914 UROGYN CUTTING LOOP ELECTRODE 24 FR. KNF OMNITECH SYSTEMS, INC. KS2-CL2414 KM02

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention