BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3081698 · Received April 29, 2013

    Report

    Report Number
    9616091-2013-00705
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 3, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES FORK STEM SNAPPED. PLEASE SEE ADDITIONAL INFORMATION ON THIS INCIDENT ON (B)(4). SEE (B)(4) FOR THE MDR FILING DECISION

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES FORK STEM SNAPPED. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183705 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 12 Other