BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGUARD (STERILE)

    MDR report key: 206869 · Received January 14, 1999

    Report

    Report Number
    1649914-1999-00001
    Event Type
    Malfunction
    Date Received
    January 14, 1999
    Date of Event
    December 10, 1998
    Report Date
    January 14, 1999
    Manufacturer
    AMERICAN OMNI MEDICAL, INC.
    Product Code
    MJJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RETROGUARD VALVE LEAKED UPON INITIATION OF BYPASS. THE CASE WAS STOPPED WHILE THE VALVE WAS CUT OUT AND REPLACED. THE CASE WAS THEN COMPLETED WITH THE NEW VALVE WITHOUT INCIDENT. NO PT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROGUARD (STERILE) ONE-WAY ARTERIAL CHECK VALVE MJJ AMERICAN OMNI MEDICAL, INC. 4007100 980314S

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN