BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 3

    MDR report key: 345682 · Received August 3, 2001

    Report

    Report Number
    2431314-2001-00001
    Event Type
    Injury
    Date Received
    August 3, 2001
    Date of Event
    June 28, 2001
    Report Date
    August 3, 2001
    Manufacturer
    BIODEX MEDICAL SYSTEMS, INC.
    Product Code
    ISD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CONCERNED PERSON HAS BEEN ATTENDED IN THE CONTINUOUS PASSIVE MOTION OF THE BIODEX PRO 3. THE PERSON WAS VERY DISQUIETINGLY AND TINKERED WITH THE DEVICE. THE CONCERNED PERSON'S LEFT TRIGGER FINGER INTERVENED BETWEEN THE ADAPTER AND THE MOTION MECHANICAL STOP OF THE DYNAMOMETER HEAD OF THE BIODEX. THE CONCERNED PERSON'S FINGER HAS BEEN SWATTED AND CONCERNED PERSON HAD TO BE ATTENDED IN THE AMBULANCE OF THE HOSPITAL. DIAGNOSIS: RIP WOUND ON THE LEFT FINGER WITH PARTIAL AMPUTATION, LEFT TRIGGER FINGER, EFIPHYSOLOYSE OF THE TERMINAL LINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35393 SYSTEM 3 MULTI-JOINT TEST & REHAB DEVICE ISD BIODEX MEDICAL SYSTEMS, INC. SYSTEM 3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability