BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVEGATE

    MDR report key: 3666650 · Received January 17, 2014

    Report

    Report Number
    2953686-2014-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2014
    Manufacturer
    GEISTER MEDIZINTECHNIK GMBH
    Product Code
    DTH
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO ESTECH. UPON REVIEWING USER FACILITY REPORT (B)(4) THE PROBABLE CAUSE WAS LIKELY DUE TO MISHANDLING.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45745 VALVEGATE SUTURE CATCHER DTH GEISTER MEDIZINTECHNIK GMBH 34-7475 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1