BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2843916 · Received November 23, 2012

    Report

    Report Number
    9616091-2012-00548
    Event Type
    Malfunction
    Date Received
    November 23, 2012
    Report Date
    November 22, 2012
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE OWNER'S MANUAL PART NUMBER 1148075, REV.B(JUL-08), 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 MALFUNCTION HAS NOT BEEN CONFIRMED. PLEASE NOTE: ANY FURTHER INFORMATION RECEIVED WILL BE FILED IN A SUPPLEMENTAL REPORT. THE END USER STATED THAT SHE HAD JUST STARTED USING THE UNIT IN THE PAST 3 MONTHS.

    Additional Manufacturer Narrative · 1

    (B)(4) SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT AWARENESS DATE ENTERED IN ERROR ON THE INITIAL REPORT.

    Description of Event or Problem · 1

    CONSUMER STATED THE SEAT CRACKED. IN SPEAKING WITH THE END USER SHE STATED THE DEALER HELPED WITH GETTING HER A NEW SEAT. SHE IS NOT SURE HOW THE SEAT CRACKED BUT GOT PINCHED ONCE SO CALLED CUSTOMER. NO INJURIES REPORTED. WAS NOT ABLE TO FIND THE SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9630-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other