BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FMS GRAVITY TUBING

    MDR report key: 2192677 · Received July 26, 2011

    Report

    Report Number
    2192677
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 26, 2011
    Manufacturer
    DEPUY MITEK, INC.
    Product Code
    GEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    FMS GRAVITY AND IRRIGATION TUBING, WAS FOUND TO HAVE A LONG HAIR INSIDE THE PACKAGE, BETWEEN THE OUTER PACKAGE AND INNER PACKAGE. PRODUCT WAS NOT OPENED AND NOT USED.====================== MANUFACTURER RESPONSE FOR FMS GRAVITY AND IRRIGATION TUBING, FMS (PER SITE REPORTER)======================MANUFACTURER PROVIDED RGA# FOR PRODUCT TRACKING AND SENT FIELD REP TO PICK UP DEFECTIVE PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMS GRAVITY TUBING IRRIGATION TUBING GEA DEPUY MITEK, INC. 281113 1064571

    Patients

    Seq Age Sex Outcome Treatment
    1 *