BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULITH, SIX-F2

    MDR report key: 3981230 · Received July 24, 2014

    Report

    Report Number
    9613347-2014-00037
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 24, 2014
    Manufacturer
    STORZ MEDICAL AG
    Product Code
    LNS
    PMA / PMN Number
    K040476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE UNDERWENT FULL SERVICE EVAL; NO PROBLEM FOUND WITH DEVICE FUNCTION AND SYSTEM WAS OPERATING WITHIN MFR'S SPECS. EVENT OCCURRED AT (B)(6) HOSPITAL.

    Description of Event or Problem · 1

    ALLEGEDLY, AFTER A LITHOTRIPSY PROCEDURE ON A BI-LATERAL AMPUTEE, PT WAS ADMITTED FOR HEMATOMA RESULTING IN AN 8 UNIT BLOOD TRANSFUSION. THERE WAS NO MALFUNCTION OF THE UNIT REPORTED. THIS EFFECT MAY BE DUE TO PT'S OVERALL CONDITION PRE PROCEDURE AND THE POSSIBLE USE OF CONTRA-INDICATED BLOOD COAGULANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435409 MODULITH, SIX-F2 LITHOTRIPTOR LNS STORZ MEDICAL AG 11000F2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention