BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRUITT-INAHARA CAROTID - LE MAITRE

    MDR report key: 967888 · Received October 19, 2007

    Report

    Report Number
    MW5004750
    Event Type
    Malfunction
    Date Received
    October 19, 2007
    Date of Event
    October 19, 2007
    Report Date
    October 19, 2007
    Manufacturer
    LEMAITRE
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THREE LEMAITRE, PRUITT-INAHARA CAROTID SHUNTS CATALOG NUMBER REF 2000-19, FROM TWO LOT NUMBERS HAD RUPTURED BALLOONS. TWO FROM LOT NUMBER 1040505-03, ONE FROM LOT NUMBER PIS1194. THEY FAILED DURING PRETESTING. DATES OF USE: ONE DAY IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRUITT-INAHARA CAROTID - LE MAITRE NONE MJN LEMAITRE PIS1194
    2 PRUIT-INAHARA CAROTID SHUNT - LE MAITRE NONE NIM LEMAITRE 1040505-03

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other