BEUDAMED
    FDA Adverse Event Other Summary report: N

    VALLEYLAB ULTRASONIC MANIFOLD TUBING SET

    MDR report key: 378811 · Received February 13, 2002

    Report

    Report Number
    1717344-2002-00014
    Event Type
    Other
    Date Received
    February 13, 2002
    Date of Event
    January 31, 2002
    Report Date
    January 31, 2002
    Manufacturer
    VALLEYLAB
    Product Code
    LBK
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REMEDIAL ACTION IS BEING TAKEN BY VALLEYLAB BECAUSE A PORTION OF THE LOT NUMBER MAY NOT HAVE BEEN APPROPRIATELY STERILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEYLAB ULTRASONIC MANIFOLD TUBING SET ULTRASONICS MANIFOLD TUBING SET LBK VALLEYLAB C3601 U12632

    Patients

    Seq Age Sex Outcome Treatment
    1 NA