BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDDICH

    MDR report key: 1061156 · Received June 10, 2008

    Report

    Report Number
    1061156
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    May 27, 2008
    Report Date
    June 10, 2008
    Manufacturer
    LEMAITRE VASCULAR INC
    Product Code
    GBZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN STATED THAT THE BALLOON DOES NOT THREAD THROUGH THE CATHETER. A REPLACEMENT WITH A DIFFERENT LOT NUMBER WAS USED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDDICH CHOLANGIOGRAM CATHETER GBZ LEMAITRE VASCULAR INC 2401-52 RST 1292

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR