BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRX

    MDR report key: 2104870 · Received May 18, 2011

    Report

    Report Number
    1523530-2011-00012
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 17, 2011
    Manufacturer
    MIDMARK CORP.
    Product Code
    NRD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE COMPRESSOR HEAD CAME APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRX UNIT, OPERATIVE DENTAL, ACCESSORIES NRD MIDMARK CORP. OL-7

    Patients

    Seq Age Sex Outcome Treatment
    1