BEUDAMED
    FDA Adverse Event Injury Summary report: N

    765 DC

    MDR report key: 2800800 · Received October 17, 2012

    Report

    Report Number
    2530069-2012-00027
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    GENDEX DENTAL SYSTEMS
    Product Code
    EHD
    PMA / PMN Number
    K992610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION HAS NOT BEEN COMPLETED. WE HAVE REQUESTED THAT THE PARTS BE RETURNED, BUT TO DATE, THE PARTS HAVE NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    WHILE TAKING X-RAYS, THE UNIT FELL OFF THE WALL AND HIT THE PT ON THE FOREHEAD. THE PT RECEIVED A CUT ON THE FOREHEAD AND WAS TAKEN TO THE FAMILY PRACTICE PHYSICIAN WHERE THEY APPLIED STERI-STRIPS. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 765 DC NONE EHD GENDEX DENTAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other