BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORNIER COMPACT DELTA II

    MDR report key: 6946090 · Received October 12, 2017

    Report

    Report Number
    1037955-2017-00046
    Event Type
    Injury
    Date Received
    October 12, 2017
    Report Date
    September 20, 2017
    Manufacturer
    DORNIER MEDTECH SYSTEMS GMBH
    Product Code
    LNS
    PMA / PMN Number
    P840008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE REPORT COMPLETED AND DATED 09/20/2017 BY A (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 COMPACT DELTA II 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. 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 REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726587 DORNIER COMPACT DELTA II LITHOTRIPTER LNS DORNIER MEDTECH SYSTEMS GMBH COMPACT DELTA II

    Patients

    Seq Age Sex Outcome Treatment
    1 Other