BEUDAMED
    FDA Adverse Event Death Summary report: N

    DORNIER COMPACT SIGMA

    MDR report key: 5964602 · Received September 20, 2016

    Report

    Report Number
    1037955-2016-00033
    Event Type
    Death
    Date Received
    September 20, 2016
    Date of Event
    August 17, 2016
    Report Date
    August 26, 2016
    Manufacturer
    DORNIER MEDTECH SYSTEMS GMBH
    Product Code
    LNS
    PMA / PMN Number
    P840008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE REPORT COMPLETED AND DATED 08/30/2016 INDICATED THAT THE DEVICE WAS IN COMPLIANCE WITH DORNIER SPECIFICATIONS. THE CUSTOMER STATED THE PATIENT WAS (B)(6) YEAR OLD MALE WHO DIED THREE (3) DAYS AFTER THE LITHOTRIPSY PROCEDURE. THE DETAILS CONCERNING THE CAUSE OF PATIENT'S DEATH ARE UNKNOWN. NO FAULT WITH THE DEVICE AS MANUFACTURED. DEVICE WAS FOUND TO BE FUNCTIONING WITHIN DORNIER SPECIFICATIONS. THIS EVENT OCCURED IN LEBANON. 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 DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613676 DORNIER COMPACT SIGMA LITHOTRIPTER LNS DORNIER MEDTECH SYSTEMS GMBH COMPACT SIGMA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death