BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 280600 · Received June 2, 2000

    Report

    Report Number
    MW1019052
    Event Type
    Injury
    Date Received
    June 2, 2000
    Report Date
    June 2, 2000
    Manufacturer
    BLOOD AND TISSUE CENTER
    Product Code
    LMO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT 1 OF 2: THE DEPT OF HEALTH WAS NOTIFIED BY A FACILITY THAT THERE MAY BE A PROBLEM WITH INFECTED TENDON GRAFTS. THE FACILITY HAS TWO PTS WHO DEVELOPED PSEUDOMONAS INFECTIONS POSTOPERATIVELY. BOTH PTS WERE TREATED WITH IV ANTIBIOTICS AND HAD EXTENDED HOSP STAYS AND PT #1 REQUIRED EXPLANTATION. IT IS UNKNOWN WHETHER THE SECOND PT'S GRAFT WAS REMOVED. CDC WAS INFORMED AND REPORTS NO OTHER KNOWN CASES. IN BOTH OF THESE CASES THE GRAFTS WERE OBTAINED FROM THE SAME DONOR.

    Description of Event or Problem · 2

    PT 2 OF 2: THE DEPT OF HEALTH WAS NOTIFIED BY A FACILITY THAT THERE MAY BE A PROBLEM WITH INFECTED TENDON GRAFTS. THE FACILITY HAS TWO PTS WHO DEVELOPED PSEUDOMONAS INFECTIONS POSTOPERATIVELY. BOTH PTS WERE TREATED WITH IV ANTIBIOTICS AND HAD EXTENDED HOSP STAYS AND PT #1 REQUIRED EXPLANTATION. IT IS UNKNOWN WHETHER THE SECOND PT'S GRAFT WAS REMOVED. CDC WAS INFORMED AND REPORTS NO OTHER KNOWN CASES. IN BOTH OF THESE CASES THE GRAFTS WERE OBTAINED FROM THE SAME DONOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK CADOVER/BIOLOGICAL TENDON LMO BLOOD AND TISSUE CENTER UNK UNK
    2 UNK CADOVER/BIOLOGICAL TENDON LMO BLOOD & TISSUE CENTER UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR
    2 UNKNOWN