BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2712553 · Received August 23, 2012

    Report

    Report Number
    9616091-2012-00275
    Event Type
    Malfunction
    Date Received
    August 23, 2012
    Report Date
    August 22, 2012
    Manufacturer
    INVAMEX
    Product Code
    INB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 9650-4. THE OWNER'S MANUAL PART NUMBER 1148075 REV B WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. 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 CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. CONSUMER STATES THAT THE COMMODE CRACKED ON THE SEAT ON BOTH SIDES. STATED PRODUCT IS ON 2 YEARS OLD AND THE DEALER SHE PURCHASED IT FROM IS NO LONGER IN BUSINESS. I DID GOODWILL PART NUMBER 1112182, ORDER NUMBER (B)(4).

    Description of Event or Problem · 1

    CONSUMER STATES THAT THE COMMODE CRACKED ON THE SEAT ON BOTH SIDES. STATED PRODUCT IS ON 2 YEARS OLD AND THE DEALER SHE PURCHASED IT FROM IS NO LONGER IN BUSINESS. I DID GOODWILL PART NUMBER 1112182, ORDER NUMBER (B)(4).

    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 75 Other