BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SURGICAL MATERIAL

    MDR report key: 2093526 · Received May 4, 2011

    Report

    Report Number
    3003898360-2011-00197
    Event Type
    Death
    Date Received
    May 4, 2011
    Report Date
    April 6, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNK IF SAMPLE IS AVAILABLE FOR INVESTIGATION. INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: A PT UNDERWENT SURGERY USING HEMOLOK CLIPS ON (B)(6) 2011. THE PT HAS PASSED AWAY, AND AT THIS TIME THE HOSPITAL IN (B)(4) IS NOT ABLE TO DETERMINE IF IT WAS DUE TO THE HEMOLOK CLIPS OR OTHER FACTORS. THE CASE HAS BEEN REPORTED TO THE CORONER. AT THE MOMENT, THE HOSPITAL IS STILL WAITING FOR THE AUTOPSY REPORT AND THE FINAL CAUSE OF DEATH TO BE ISSUED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED IN TIME FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SURGICAL MATERIAL UNK FZP TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death