BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORNIER GEMINI

    MDR report key: 5869881 · Received August 11, 2016

    Report

    Report Number
    1037955-2016-00026
    Event Type
    Injury
    Date Received
    August 11, 2016
    Date of Event
    July 20, 2016
    Report Date
    July 26, 2016
    Manufacturer
    DORNIER MEDTECH SYSTEMS GMBH
    Product Code
    LNS
    PMA / PMN Number
    K121656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE REPORT COMPLETED AND DATED (B)(6) 2016 BY A DORNIER MEDTECH (B)(4) FIELD SERVICE ENGINEER INDICATED THAT THE DEVICE WAS IN COMPLIANCE WITH DORNIER SPECIFICATIONS. A HEMATOMA IS LISTED AS A POTENTIAL ADVERSE EFFECT AND COMPLICATION IN THE DORNIER GEMINI OPERATING MANUAL. THE DETAILS CONCERNING INDIVIDUAL PATIENT OUTCOMES ARE UNKNOWN. NO FAULT WITH THE DEVICE AS MANUFACTURED. DEVICE WAS FOUND TO BE FUNCTIONING WITHIN DORNIER SPECIFICATIONS. THIS EVENT OCCURED IN GERMANY. 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 HEMATOMA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523024 DORNIER GEMINI LITHOTRIPTER LNS DORNIER MEDTECH SYSTEMS GMBH GEMINI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other