BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGIANCE SILICONIZED CATHETER

    MDR report key: 515730 · Received March 15, 2004

    Report

    Report Number
    9611710-2004-00003
    Event Type
    Injury
    Date Received
    March 15, 2004
    Date of Event
    January 20, 2004
    Report Date
    March 6, 2004
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FORMING CRYSTALS -CAUSING UTI'S - LEAKING TURNS BLUE -GROWING INTO THE UNOMEDICAL'S DISTRIBUTOR. " UNOMEDICAL SDN. BHD" THE MFR OF THE DEVICE ONLY RECEIVED THE OFFICIAL COMPLAINT NOTIFICATION (PRODUCT QUALITY REPORT) FROM DISTRIBUTOR IN FEBURARY, 2004. AFFECTED SAMPLE WAS NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGIANCE SILICONIZED CATHETER SILICONIZED CATHETER KOD UNOMEDICAL SDN BHD PE516 2002-G-04R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R