BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2821834 · Received November 6, 2012

    Report

    Report Number
    9616091-2012-00498
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    September 1, 2012
    Report Date
    November 6, 2012
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TRSX5RC8, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY TWO MONTH OLD. THE OWNER'S MANUAL PART NUMBER 1110550 REV. G (FEB-11) 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 CONSUMER IS A (B)(6) MALE, AND WEIGHT (B)(6). HOWEVER, HIS HEIGHT IS UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE AND THE MAINTENANCE HISTORY OF THE DEVICE ARE UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(6) - IT WAS REPORTED BY THE CONSUMER'S DAUGHTER THAT THE TRSX5RC8 RECLINER WHEELCHAIR WAS THE WRONG SIZE FOR HER FATHER, WHO WAS NEVER MEASURED FOR THE UNIT, WHICH HAD THE SEAT TOO LOW, THE LENGTH OF ARMREST AND FOOTREST WERE TOO SHORT, RESULTING IN PRESSURE SORES ON BOTH FEET. THE PATIENT WAS UNABLE TO STAND UP DUE TO HIS INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX5RC8

    Patients

    Seq Age Sex Outcome Treatment
    1 78 Other