BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL BLOCK TRAY

    MDR report key: 3832009 · Received March 7, 2014

    Report

    Report Number
    1722447-2014-00004
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Report Date
    February 21, 2014
    Manufacturer
    INTEGRA PAIN MANAGEMENT
    Product Code
    FMF
    PMA / PMN Number
    K960248
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTS 1 TRAY WITH DUST INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138782 UNIVERSAL BLOCK TRAY 44 TRAYS FMF INTEGRA PAIN MANAGEMENT W1312155

    Patients

    Seq Age Sex Outcome Treatment
    1