BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2328924 · Received November 9, 2011

    Report

    Report Number
    9616091-2011-00072
    Event Type
    Malfunction
    Date Received
    November 9, 2011
    Report Date
    November 8, 2011
    Manufacturer
    INVAMEX
    Product Code
    INB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 9650-4, SERIAL NUMBER/DATE CODE XXXX IS APPROXIMATELY XXXX AGE. THE USER MANUAL PART NUMBER 1023891 WAS ISSUED WITH THIS DEVICE. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    THE SEATS ARE ALLEGEDLY CRACKING ON THE COMMODES. THE DEALER ALLEGEDLY HAS BEEN RECEIVING MANY COMPLAINTS FROM CONSUMERS ABOUT THIS ISSUE WITHIN MONTHS OF USE AND SOME OF THE COMMODES ALLEGEDLY HAVE CRACKED SEATS OUT OF THE BOX. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 INB INVAMEX 9650-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other