BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVAL MESH, DIA./HGT. UNK

    MDR report key: 246635 · Received October 28, 1999

    Report

    Report Number
    1818910-1999-00181
    Event Type
    Injury
    Date Received
    October 28, 1999
    Date of Event
    June 18, 1998
    Report Date
    October 28, 1999
    Manufacturer
    DEPUY MOTECH, INC.
    Product Code
    JDN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDWATCH WAS FAXED FROM ACROMED AND SENT TO THEM BY FDA. THE COMPLAINANT SEEMS TO BE THE PT WHO IS IDENTIFIED ONLY AS A 45 YEAR OLD FEAMLE; WEIGHING 136. THE DEVICE IS IDENTIFIED AS DEPUY MOTECH TITANIUM SURGICAL MESH. THEY IDENTIFY K NUMBER 900138 FOR VERIFICATION. DEVICE WAS IMPLANTED IN 1998. WITHIN 3 WEEKS IT EXTRUDED INTO THE INFERIOR VENA CAVA. ON 7/31/1998 PT HEMORRHAGED WITH SIGNIFICANT BLOOD LOSS AND RECEIVED TRANSFUSIONS. SHE WAS REVISED AND THE VENA CAVA WAS REPAIRED. A BONE SCREW WAS USED. FIFTEEN DAYS POST EXPLANT THE PT WAS READMITTED WITH BLOOD CLOTS IN BOTH LEGS AND THE INFERIOR VENA CAVA. SHE WAS HOSPITALIZED FOR FOUR WEEKS AND RECEIVED A GREENFIELD VENA CAVA FILTER REPLACEMENT. SHE SUFFERED FURTHER EMBOLISM AND IS NOW LEGALLY DISABLED WITH NO PERIPHERAL VISION DUE TO EMBOLISMS OF THE EYE. SEE MEDWATCH FOR REST OF THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVAL MESH, DIA./HGT. UNK Implant SPINAL FIXATION JDN DEPUY MOTECH, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| S