BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGICAL UNK DUMMY MATERIAL

    MDR report key: 4245020 · Received November 6, 2014

    Report

    Report Number
    3003898360-2014-00894
    Event Type
    Death
    Date Received
    November 6, 2014
    Date of Event
    March 21, 2014
    Report Date
    October 16, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    MCH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. FAILURE MODE "CLIP SLIPPED OFF VESSEL" WAS UNABLE TO BE CONFIRMED WITH THE PICTURE THAT WAS SUBMITTED BY THE CUSTOMER. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO LACK OF PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. HOWEVER, THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS. RESULTS - NO RESULT CODE AVAILABLE THAT COULD ACCURATELY DESCRIBE THAT THE COMPLAINT WAS CONFIRMED, BUT THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    ALLEGED ISSUE: CUSTOMER REPORTED THAT THEY TOOK THEIR GERMAN SHEPHERD TO BE SPAYED, BUT DEATH OCCURRED DUE TO BLEEDING AFTER THE SURGERY, BECAUSE THE HEMOCLIP CAME OFF. THE VET STATED THAT A HEMOLOK LIGATING CLIP WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714278 SURGICAL UNK DUMMY MATERIAL HEMOCLIP LARGE UNK MCH TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death