BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 568777 · Received January 31, 2005

    Report

    Report Number
    1124603-2005-00002
    Event Type
    Other
    Date Received
    January 31, 2005
    Date of Event
    July 10, 2003
    Report Date
    January 26, 2005
    Manufacturer
    LIFENET
    Product Code
    LMO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A SUBOCCIPITAL CRANIECTOMY AND C1 LAMINECTOMY WITH DURAL PATCH GRAFT IN 2003. PT WAS DISCHARGED SIX DAYS LATER. PT RETURNED TO E.D. THE NEXT DAY WITH COMPLAINT OF WORSENED HEADACHE AND FEVER. READMITTED POST-OP MENINGITIS. RETURNED TO OR TWO DAYS LATER. REVISION OF SUBOCCIPITAL CRANIECTOMY FOR I&O WITH PLACEMENT OF EVD CATHETER. DURAL GRAFT REMOVED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PERICARDIUM GRAFT LMO LIFENET NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| O