BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER LIFT W/LOW BASE-PLUS 9153633519

    MDR report key: 4842800 · Received June 13, 2015

    Report

    Report Number
    9616091-2015-01573
    Event Type
    Malfunction
    Date Received
    June 13, 2015
    Report Date
    May 21, 2015
    Manufacturer
    INVAMEX
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THE CONSUMER STATED THE LEGS WILL SPREAD ON ITS OWN. NO INJURY OR PROPERTY DAMAGE HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386813 POWER LIFT W/LOW BASE-PLUS 9153633519 LIFT, PATIENT, NON-AC-POWERED FSA INVAMEX RPL450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other