BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT DELTA II

    MDR report key: 7968648 · Received October 16, 2018

    Report

    Report Number
    1037955-2018-00061
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    September 6, 2018
    Report Date
    September 27, 2018
    Manufacturer
    DORNIER MEDTECH SYSTEMS GMBH
    Product Code
    LNS
    PMA / PMN Number
    P840008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE REPORT COMPLETED AND DATED 09/26/2018 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 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. (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
    810581 COMPACT DELTA II LITHOTRIPTER LNS DORNIER MEDTECH SYSTEMS GMBH COMPACT DELTA II

    Patients

    Seq Age Sex Outcome Treatment
    1 Other