BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORNIER DELTA III

    MDR report key: 8623459 · Received May 20, 2019

    Report

    Report Number
    1037955-2019-00016
    Event Type
    Injury
    Date Received
    May 20, 2019
    Report Date
    April 22, 2019
    Manufacturer
    DORNIER MEDTECH SYSTEMS GMBH
    Product Code
    LNS
    PMA / PMN Number
    K172084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE REPORT COMPLETED AND DATED 04/22/2019 BY A DMTA 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 DELTA III OPERATING MANUAL. THE DETAILS CONCERNING INDIVIDUAL PATIENT OUTCOMES ARE UNKNOWN. NO FAULT WITH THE DEVICE AS MANUFACTURED. DORNIER MEDTECH AMERICA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF DORNIER MEDTECH SYSTEMS GMBH (MANUFACTURER) PER EXEMPTION E2012002.

    Description of Event or Problem · 0

    PATIENT HEMATOMA REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416467 DORNIER DELTA III LITHOTRIPTER LNS DORNIER MEDTECH SYSTEMS GMBH DORNIER DELTA III

    Patients

    Seq Age Sex Outcome Treatment
    1 Other