BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMBAR EXTENSION MACHINE

    MDR report key: 335696 · Received May 29, 2001

    Report

    Report Number
    1051095-2001-00001
    Event Type
    Injury
    Date Received
    May 29, 2001
    Date of Event
    March 19, 2001
    Report Date
    April 3, 2001
    Manufacturer
    MEDX 96, INC.
    Product Code
    ION
    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

    WHILE PARTICIPATING IN A CERTIFICATION COURSE FOR THE MEDX LUMBAR EXTENSION MACHINE AT THE UNIVERSITY, THE CLAIMANT ALLEGES TO HAVE INJURED BACK. THE CLAIMANT WAS BEING INSTRUCTED IN THE OPERATION OF THE MACHINE. THE CLAIMANT CLAIMS TO HAVE INJURED BACK PERFORMING THE RANGE OF MOTION TEST. WHEN STARTING AT 72 DEGREES FLEXION, THE CLAIMANT FELT TWO "POPS" IN LOWER BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24949 LUMBAR EXTENSION MACHINE MEASURING EXERCISE MACHINE ION MEDX 96, INC. MEDX LUMBAR *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention