BEUDAMED
    FDA Adverse Event Death Summary report: N

    DORNIER COMPACT DELTA II LITHOTRIPTER

    MDR report key: 4364061 · Received December 22, 2014

    Report

    Report Number
    1037955-2014-00021
    Event Type
    Death
    Date Received
    December 22, 2014
    Report Date
    December 22, 2014
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    LNS
    PMA / PMN Number
    P840008
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE REPORT COMPLETED (B)(4) 2014 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 CUSTOMER STATED THAT THE PT WHO DIED WAS A (B)(6) YR OLD MALE WHO DIED 10 DAYS AFTER THE LITHOTRIPSY PROCEDURE AS THE RESULT OF AN INTERNAL HEMATOMA. NO FAULT WITH THE DEVICE WAS MANUFACTURED. DEVICE WAS FOUND TO BE FUNCTIONING WITHIN DORNIER SPECIFICATIONS. DORNIER (B)(4) (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF DORNIER (B)(4) (THE MFR) PER EXEMPTION NUMBER(B)(4).

    Description of Event or Problem · 1

    PT DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841627 DORNIER COMPACT DELTA II LITHOTRIPTER LITHOTRIPTER LNS DORNIER MEDTECH AMERICA, INC. K1026739

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death