BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORNIER RELAX + TABLE

    MDR report key: 8387304 · Received March 4, 2019

    Report

    Report Number
    1037955-2019-00004
    Event Type
    Injury
    Date Received
    March 4, 2019
    Date of Event
    February 11, 2019
    Report Date
    February 12, 2019
    Manufacturer
    DORNIER MEDTECH SYSTEMS GMBH
    Product Code
    LNS
    PMA / PMN Number
    P840008
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE REPORT COMPLETED 02/15/2019 INDICATED THAT THE RELAX+ TABLE USED BY THE CUSTOMER WAS IN COMPLIANCE WITH DORNIER SPECIFICATIONS. THE DORNIER RELAX+ TABLE COULD NOT BE THE ROOT CAUSE OF THE PATIENT INCIDENT IF IT WAS USED CORRECTLY. IT IS LIKELY THAT STAFF POSITIONED THE PATIENT ON THE INCORRECT SIDE OF THE TABLE CAUSING THE PATIENT TO FALL OFF THE FOOT EXTENSION DAMAGING THE DRAIN BAG ASSEMBLY. THE NEW DRAIN BAG ASSEMBLY WAS REPLACED AND INSTALLED ON 02/14/2019. THE DORNIER DISTRICT SERVICE MANAGER THEN TRAINED THE UROLOGY STAFF ON PROPER USE OF THE RELAX+ TABLE ON 02/14/2019. NO FAULT WITH THE DEVICE AS MANUFACTURED. DORNIER MEDTECH AMERICA, INC. (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF DORNIER MEDTECH SYSTEMS GMBH (THE MANUFACTURER) PER EXEMPTION NUMBER E2012002.

    Description of Event or Problem · 0

    "PATIENT FELL OFF TABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179684 DORNIER RELAX + TABLE RELAX + TABLE LNS DORNIER MEDTECH SYSTEMS GMBH K1018869

    Patients

    Seq Age Sex Outcome Treatment
    1