BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRYOPATCH HUMAN GRAFT

    MDR report key: 433909 · Received December 26, 2002

    Report

    Report Number
    MW1027063
    Event Type
    Death
    Date Received
    December 26, 2002
    Date of Event
    May 25, 2002
    Report Date
    December 26, 2002
    Manufacturer
    CRYOLIFE
    Product Code
    LMO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT DIED. MD DOES NOT BELIEVE DEATH HAS ANYTHING TO DO WITH THE DEVICE BUT THERE WAS A CRYOLIFE RECALL IN AUGUST AND A REQUEST WAS MADE TO REPORT ANY DEATHS. THE VALVE WAS AFFECTED BY THE RECALL BUT MD DOES NOT BELIEVE THE DEATH HAS ANYTHING TO DO WITH THE STATED RECALL CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOPATCH HUMAN GRAFT PATCH MATERIAL LMO CRYOLIFE PULMONARY HEMI-ARTERY *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Death