BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMX425

    MDR report key: 7506529 · Received May 11, 2018

    Report

    Report Number
    2183461-2018-00001
    Event Type
    Injury
    Date Received
    May 11, 2018
    Date of Event
    July 29, 2016
    Report Date
    April 11, 2018
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    IOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ALLEGATION OF MALFUNCTION. THE PATIENT WAS ON THE TREADMILL AND WHEN THE STAGE CHANGED AT 4 MIN, THE PATIENT FELL ON HER LEFT SIDE. SHE SUSTAINED INJURIES TO HER LEFT SHOULDER AND LEFT KNEE WHICH HAVE LEFT HER WITH LOSS OF MOTION AND PAIN IN THE LEFT SHOULDER AND DISCOMFORT IN THE LEFT KNEE. THE PATIENT WAS SERIOUSLY INJURED AS DEFINED BY FDA DUE TO PERMANENT INJURY. THIS TREADMILL IS INTENDED TO BE USED DURING STRESS TESTING. IT IS EQUIPPED WITH AN EMERGENCY STOP BUTTON FOR THE PATIENT AS WELL AS CAN BE STOPPED BY THE CLINICIAN USING THE STRESS SYSTEM THAT IS CONTROLLING IT. FURTHERMORE, STANDARD OF CARE DICTATES THAT EXERCISE STRESS TESTS ON TREADMILLS ARE CLOSELY SUPERVISED.

    Description of Event or Problem · 1

    MORTARA INSTRUMENT RECEIVED A REPORT FROM THE ACCOUNT STATING A PATIENT FELL DURING AN EXERCISE STRESS TEST FROM THE TREADMILL. THE TREADMILL WAS LOCATED AT THE ACCOUNT. THE COMPLAINT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350790 TMX425 TREADMILL IOL MORTARA INSTRUMENT, INC. FVMILL-AAA-EABAB

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Disability