BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 2418360 · Received January 17, 2012

    Report

    Report Number
    2950727-2012-00001
    Event Type
    Death
    Date Received
    January 17, 2012
    Report Date
    April 10, 2012
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Additional Manufacturer Narrative · 1

    ACCORDING THE REPORT, THE PATIENT RECEIVED TMR AND EXPIRED WITHIN 24 HOURS OF THE PROCEDURE DUE TO EDEMA. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON. HOWEVER, THESE ATTEMPTS DID NOT YIELD ADDITIONAL COMPLAINT DETAILS. A REVIEW OF SHIPPING RECORDS TO THE FACILITY YIELDED ONE POSSIBLE LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT INDICATES THAT THE LOT WAS MANUFACTURED ACCORDING TO ALL SPECIFICATION. WITH THE AVAILABLE INFORMATION NO CONCLUSIONS REGARDING THE EVENT CAN BE DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AT A LATER DATE THE COMPLAINT WILL BE REOPENED AND THE INFORMATION WILL BE EVALUATED. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO IS ACCURATE OR HAS BEEN CONFIRMED.

    Description of Event or Problem · 1

    ACCORDING THE REPORT, THE PATIENT RECEIVED TMR AND EXPIRED WITHIN 24 HOURS OF THE PROCEDURE DUE TO EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLOGRIP III HANDPIECE TMR HANDPIECE DEVICE MNO CARDIOGENESIS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death