BEUDAMED
    FDA Adverse Event Death Summary report: N

    POST OP LITE SHORT

    MDR report key: 1671369 · Received April 27, 2010

    Report

    Report Number
    2028253-2010-00008
    Event Type
    Death
    Date Received
    April 27, 2010
    Report Date
    April 26, 2010
    Manufacturer
    BREG
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD A POST OP LITE SHORT FOLLOWING SURGERY AND WAS THEN TRANSFERRED TO A NURSING HOME. THE PT'S WOUND BECAME INFECTED AT A NURSING HOME WHICH RESULTED IN A BELOW THE KNEE AMPUTATION. THE PT WAS (B) (6) AND WAS DIAGNOSED WITH A TIBIAL FRACTURE WHICH REQUIRED A 2-3 DAY HOSPITAL STAY IN (B) (6) 2008. THE PT WAS THEN DISCHARGED TO A NURSING HOME WITH POST OP BANDAGING, TEDHOSE, A GEL CAST ANKLE STIRRUP AND THE BREG POST OP LITE. THE PT WAS IN THE NURSING HOME FOR APPROXIMATELY 25 DAYS WITHOUT ANY CHECKS OR CHANGING OF THE BANDAGING, TEDHOSE, STIRRUP OR BREG POST OP LITE RESULTING IN AN INFECTION OF THE WOUND SITE. A BELOW THE KNEE AMPUTATION WAS REQUIRED AFTER THE INFECTION THEN, THE PT PASSED AWAY SOMETIME AFTER (DATE NOT AVAILABLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POST OP LITE SHORT 89 IQI IQI BREG

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death| S