BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGUARD ARTERIAL SAFETY VALVE

    MDR report key: 810051 · Received October 25, 2006

    Report

    Report Number
    1649914-2006-00107
    Event Type
    Malfunction
    Date Received
    October 25, 2006
    Report Date
    October 24, 2006
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    MJJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RETROGUARD VALVE CRACKED AND LEAKED. THE SAMPLE WAS SAVED AND WILL BE RETURNED TO QUEST. PRODUCT CODE 4007200; LOT NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROGUARD ARTERIAL SAFETY VALVE FLOW CHECK VALVE MJJ QUEST MEDICAL, INC. 4007200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR