BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2636709 · Received July 2, 2012

    Report

    Report Number
    1531186-2012-00456
    Date Received
    July 2, 2012
    Date of Event
    June 6, 2012
    Report Date
    June 29, 2012
    Manufacturer
    POPULAR PLASTICS
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)- NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 9780, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 YEAR AND 8 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1122173 REV C (JAN-09) WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S 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 AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE CUSTOMER ALLEGED NO INJURY. THE CUSTOMER ALLEGED MALFUNCTION; CRACKED IN THE SHOWER CHAIR. THE PRODUCT IS WARRANTED (#(B)(4)) WAS ISSUED TO RESOLVED CUSTOMER ISSUE. THIS IS A WEIGHT BEARING DEVICE AND THERE IS A POTENTIAL FOR INJURY. MDR FILED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THE SEAT CRACKED IN THE MIDDLE ABOVE SHOWER CHAIR. WARRANTY #(B)(4). NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX POPULAR PLASTICS 9780

    Patients

    Seq Age Sex Outcome Treatment
    1 Other