BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 2034724 · Received March 23, 2011

    Report

    Report Number
    2248721-2011-00048
    Event Type
    Other
    Date Received
    March 23, 2011
    Report Date
    March 16, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GKP
    PMA / PMN Number
    K951072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO PRODUCT RETURNED. RESULT: NONE. CONCLUSION: NO CONCLUSION CAN BE DRAWN. IT IS THE COMPANY'S PRACTICE TO REPORT ALL INSTANCES WHERE THE DEATH OF A PT OR USER IS MADE KNOWN TO THE COMPANY IRRESPECTIVE OF THE ROLE OF THE COMPANY'S PRODUCT IN THE DEATH. IN THIS CASE, THERE IS NO KNOWN OR SUSPECTED CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND THE DEATH. THIS REPORT IS BEING PROVIDED STRICTLY ON AN INFO BASIS. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS ONE FATAL HAEMORRHAGE DUE TO AN ACUTE SUBDURAL HEMATOMA AFTER AN ACCIDENTAL FALL. THIS EVENT WAS NOT ASSOCIATED WITH A PROBLEM OF INR. THIS EVENT OCCURRED OUTSIDE THE US DURING THE COURSE OF A PHARMACEUTICAL CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTIME MICROCOAGULATION SYSTEM GKP INTERNATIONAL TECHNIDYNE CORP. PROPH220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other