BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER

    MDR report key: 2163554 · Received July 11, 2011

    Report

    Report Number
    MW5021319
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELECTIVE ADMISSION FOR ATRIAL SEPTAL DEFECT (ASD) CLOSURE. A 15-MM AMPLATZER SEPTAL OCCLUDER WAS PLACED UNDER GENERAL ANESTHESIA. POST OP, THE PATIENT HAD BLOODY URINE AND POOR APPETITE. A CHEST X-RAY AND ECHO CONFIRMED DISPLACEMENT OF THE SEPTAL OCCLUDER. PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER 15 MM MLV AGA MEDICAL CORPORATION 9-ASD-015 M08J16-34

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization| S