BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRSX5RC/WD66/28/R/U240 9153641587

    MDR report key: 5678128 · Received May 25, 2016

    Report

    Report Number
    9616091-2016-00679
    Event Type
    Malfunction
    Date Received
    May 25, 2016
    Report Date
    February 23, 2012
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MDR IS BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE COMPLAINT REVIEW. NOT ENOUGH PARTS WERE RETURNED (ONLY THE ANTI-RATTLE RECLINER PART 1024221 WAS RETURNED) SO NO EVALUATION WAS PERFORMED. THEREFORE, THE COMPLAINT COULD NOT BE VERIFIED. THE UNDERLYING CAUSE OF THE COMPLAINT ISSUE COULD NOT BE DETERMINED AFTER REVIEWING THE DOCUMENTATION IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    NEW CHAIR, BACK JUST FALLS DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333637 TRSX5RC/WD66/28/R/U240 9153641587 WHEELCHAIR, MECHANICAL IOR INVAMEX TRSX5RC

    Patients

    Seq Age Sex Outcome Treatment
    1