BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFENET

    MDR report key: 554174 · Received September 13, 2004

    Report

    Report Number
    MW1033586
    Event Type
    Injury
    Date Received
    September 13, 2004
    Date of Event
    August 9, 2004
    Report Date
    September 13, 2004
    Manufacturer
    *
    Product Code
    LMO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PT HAD AN ACL RECONSTRUCTION OF THE RIGHT KNEE WITH A CADAVER GRAFT. A COUPLE OF DAYS PRIOR TO ADMISSION PT WAS NOT FEELING WELL, HAD SOME INCREASED SWELLING AND PAIN. TWO DAYS PRIOR TO ADMISSION, PT WAS PUT ON DURICEF. ON THE DAY OF ADMISSION, PT WOKE UP WITH EXCRUCIATING PAIN IN THE RIGHT KNEE AND WENT TO THE DR'S OFFICE. PT WAS ADMITTED AND TAKEN TO SURGERY FOR INCISION AND DRAINAGE; THE GRAFT WAS VISUALIZED AND LOOKED FINE. PT WAS SUBSEQUENTLY DISCHARGED HOME THE NEXT DAY WITH ORDER FOR IV ROCEPHIN. CULTURES GREW OUT SERRATIA. THE PT WAS READMITTED THE NEXT DAY AND HAD ANOTHER INCISION AND DRAINAGE THE FOLLOWING DAY. PT WAS DISCHARGED HOME THE NEXT DAY TO CONTINUE ON IV ZOSYN. APPROX 40 HOURS PRIOR TO READMISSION ON 15 DAYS LATER, PT STARTED TO SPIKE TEMPERATURES, BUT NO KNEE PAIN. OF CONCERN AT THAT POINT WAS LOW WHITE COUNT OF 1.7. PT PICC LINE WAS EXAMINED WITH NO EVIDENCE OF ANY AREA OF ERYTHEMA OR DRAINAGE. THE INFECTIOUS DISEASE PHYSICIAN'S IMPRESSION WAS FEVER LEUKOPENIA, RULE OUT BONE MARROW SUPPRESSION SECONDARY TO THE ANTIOBIOTIC ZOSYN. PT WAS SUBSEQUENTLY DISCHARGED 2 DAYS LATER, AGAIN ON IV ROCEPHIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFENET CADAVER GRAFT LMO * UNOS #03-4508-004 *

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization