BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL BLOCK TRAY

    MDR report key: 3231849 · Received July 15, 2013

    Report

    Report Number
    1722447-2013-00011
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Report Date
    July 15, 2013
    Manufacturer
    INTEGRA PAIN MANAGEMENT
    Product Code
    FMF
    PMA / PMN Number
    K960248
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 FOUND A BUG IN 2 OF THEIR TRAYS AND HAD 4 TRAYS WITH TORN WRAPS. THE CUSTOMER IS RETURNING 1 TRAY WITH THE BUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326719 UNIVERSAL BLOCK TRAY 44 - TRAYS FMF INTEGRA PAIN MANAGEMENT W1212117

    Patients

    Seq Age Sex Outcome Treatment
    1