BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRUE-SIZE OBTURATOR

    MDR report key: 218484 · Received April 8, 1999

    Report

    Report Number
    6000002-1999-00084
    Event Type
    Other
    Date Received
    April 8, 1999
    Date of Event
    March 10, 1999
    Report Date
    March 10, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED THAT THE SURGEON USED MODEL 1161 FOR SIZING THE PT'S ANNULUS. DURING SIZING, THE DR PULLED THE DEVICE OUT AND HE NOTED THAT THE 'BARRELL' AND 'ARMS' WERE MISSING. THE DR WAS ABLE TO RETRIEVE THE 'BARRELL' AND 20 OUT OF THE 3 'ARMS'. THIS MISSING 'ARM' WAS IN THE PT'S VENTRICLE. THE DR LOOKED FOR THE PIECE IN THE VENTRICLE, BUT WAS UNABLE TO LOCATE IT. NO PT INJURY WAS REPORTED. THIS DEVICE IS EXPECTED TO BE RETURNED FOR AN EVALUATION, BUT HAS NOT BEEN REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUE-SIZE OBTURATOR OBTURATOR DTI BAXTER HEALTHCARE CORP. 1161 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention