BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCUSHUNT

    MDR report key: 44343 · Received October 8, 1996

    Report

    Report Number
    1713910-1996-00023
    Event Type
    Malfunction
    Date Received
    October 8, 1996
    Date of Event
    July 29, 1996
    Report Date
    September 8, 1996
    Manufacturer
    RESEARCH MEDICAL INC
    Product Code
    DQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THE PRIME PROCEDURE OF A CAROTID SHUNT, THE STOPCOCK SEPERATED FROM THE INFLATION LINE. THE PT WAS NOT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCUSHUNT SILICONE BALLOON SHUNT DQR RESEARCH MEDICAL INC NA 87934

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other