BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINSCAN

    MDR report key: 184381 · Received August 26, 1998

    Report

    Report Number
    MW1014486
    Event Type
    Malfunction
    Date Received
    August 26, 1998
    Date of Event
    August 20, 1998
    Report Date
    August 25, 1998
    Manufacturer
    LINSCAN SYSTEMS, INC.
    Product Code
    MGK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DRAPES BEING USED FOR ECHO ULTRASOUND ARE CHECKED FOR LEAKS PRIOR TO PROCEDURE. FILLED DRAPES WITH WATER AND HOLES WERE EVIDENT. SEVEN DRAPES WERE FOUND TO BE DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINSCAN DRAPES MGK LINSCAN SYSTEMS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other