BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2864109 · Received December 10, 2012

    Report

    Report Number
    9616091-2012-00622
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    December 7, 2012
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4) - NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES BRACKET WHERE THE ARM ATTACHES TO HAS BROKEN AT THE WELD. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other