BEUDAMED
    FDA Adverse Event Other Summary report: N

    METRIX

    MDR report key: 615901 · Received January 19, 2005

    Report

    Report Number
    1937141-2005-00001
    Event Type
    Other
    Date Received
    January 19, 2005
    Date of Event
    January 19, 2005
    Report Date
    January 19, 2005
    Manufacturer
    METRIX CO.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE LEG PUMP SETS HAVE LEAKING ISSUES WHEN USED IN CLEANROOM TO COMPOUND PRODUCTS. "AUTOMATIC SHUT OFF VALVE" APPEARS TO FAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METRIX ONE LEG PUMP SETS FPA METRIX CO. 58771 13798

    Patients

    Seq Age Sex Outcome Treatment
    1 *