BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOLIFE, INC.

    MDR report key: 168730 · Received May 19, 1998

    Report

    Report Number
    168730
    Event Type
    Injury
    Date Received
    May 19, 1998
    Date of Event
    March 27, 1998
    Report Date
    May 15, 1998
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    LMO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD REPAIR ON ANTERIOR CRUCIATE LIGAMENT WITH DONOR ALLOGRAFT ON 3/27/98. READMITTED TO HOSP ON 4/7/98 WITH "FLUID ON KNEE". WOUND CULTURE COLLECTED 4/7/98. FINAL REPORT SHOWED "CLOSTRIDIUM SPECIES IDENTIFIED AS CLOSTRIDIUM SEPTICUM - BETA LACTAMASE NEGATIVE." BLOOD CULTURE NEGATIVE. PT RECEIVED A PERIPHERALLY INSERTED CENTRAL CATHETER LINE FOR TWO WEEKS OF IV ANTIBIOTIC THERAPY. READMITTED 5/1/98 FOR INCISION AND DRAINAGE OF WOUND. ALLOGRAFT WAS CULTURED AT TIME OF IMPLANT 3/27/98. REPORTED BACK 4/22/98 AS "CLOSTRIDIUM SORDELLI - BETA LACTAMASE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOLIFE, INC. Implant HEMI PATELLAR TENDON-DONOR ALLOGRAFT LMO CRYOLIFE, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R ARTHROSCOPE