BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRES

    MDR report key: 480002 · Received August 21, 2003

    Report

    Report Number
    6000136-2003-00002
    Event Type
    Malfunction
    Date Received
    August 21, 2003
    Report Date
    April 9, 2003
    Manufacturer
    LAKE REGION MFG, INC.
    Product Code
    DQX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A TREATMENT PROCEDURE, THE CUSTOMER FELT THE WIRE WAS STIFFER THAN NORMAL. NO PT INJURIES OR COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRES PTCA GUIDEWIRE DQX LAKE REGION MFG, INC. GUIDEWIRE, .035, 150CM 01814608

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN