BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILMED

    MDR report key: 1944051 · Received December 27, 2010

    Report

    Report Number
    MW5018737
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    December 13, 2010
    Report Date
    December 27, 2010
    Manufacturer
    STERILMED
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CATHETER NOT ABLE TO BEND WHEN PLACED IN THE BODY. FOUND OUT STERILMED CATHETER HAS BEEN REPROCESSED THREE TIMES. THIS SHOULD HAVE NOT PASSED STERILMED'S QC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILMED BIOSENSE WEBSTER LASSO DQO STERILMED 3944301 958839

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR