BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTTO BOCK

    MDR report key: 195009 · Received October 28, 1998

    Report

    Report Number
    2182293-1998-00001
    Event Type
    Injury
    Date Received
    October 28, 1998
    Date of Event
    August 7, 1998
    Report Date
    August 10, 1998
    Manufacturer
    OTTO BOCK ORTHOPEDIC INDUSTRY, INC.
    Product Code
    ISY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RECEIVED A PHONE CALL ADVISING THAT AN AMPUTEE FORMERLY TREATED BY ANOTHER FACILITY HAD REPORTEDLY FALLEN WHILE WEARING A 3R60 KNEE AND FRACTURED HIS NON-AMPUTATED LEG. THE PATIENT IS REPORTED TO BE SCHEDULED FOR SURGERY TO REPAIR THE FRACTURE AND WILL THEN RESUME AMBULATION. THE AMPUTEE IS REPORTED TO HAVE TOLD THE OTHER FACILITY STAFF THAT THE KNEE WAS NOT FUNCTIONING PROPERLY A FEW DAYS EARLIER, AND WAS ALLEGEDLY ADVISED TO CONTINUE USING IT. THE FALL OCCURRED SHORTLY AFTER. CO HAS PROVIDED THE PATIENT WITH A NEW KNEE AND WILL FORWARD THE KNEE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTTO BOCK KNEE FOR ARTIFICIAL LIMB ISY OTTO BOCK ORTHOPEDIC INDUSTRY, INC. 3R60 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R