BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2143177 · Received June 28, 2011

    Report

    Report Number
    1525712-2011-00306
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    May 12, 2011
    Report Date
    October 6, 2011
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ALLEGED SERIOUS INJURY. ALLEGED MALFUNCTION. BASED ON INFORMATION FROM IVC LEGAL ALLEGING THAT A CONSUMER WAS SERIOUSLY INJURED BY AN ALLEGEDLY DEFECTIVE UNSPECIFIED INVACARE WHEELCHAIR AN MDR WILL BE FILED. NO OTHER DETAILS ON THE INJURY OR THE DEVICE HAVE BEEN PROVIDED. FOLLOW-UP 06OCT2011 - (B)(4) THE MODEL IS 9000 SL WHEEL CHAIR - (B)(4) AND THE SERIAL NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    ALLEGED SERIOUS INJURY. ALLEGED MALFUNCTION. BASED ON INFORMATION FROM IVC LEGAL ALLEGING THAT A CONSUMER WAS SERIOUSLY INJURED BY AN ALLEGEDLY DEFECTIVE UNSPECIFIED INVACARE WHEELCHAIR AN MDR WILL BE FILED. NO OTHER DETAILS ON THE INJURY OR THE DEVICE HAVE BEEN PROVIDED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION FROM IVC LEGAL ALLEGING THAT A CONSUMER WAS SERIOUSLY INJURED BY AN ALLEGEDLY DEFECTIVE UNSPECIFIED INVACARE WHEELCHAIR. NO OTHER DETAILS HAVE BEEN PROVIDED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION FROM IVC LEGAL ALLEGING THAT A CONSUMER WAS SERIOUSLY INJURED BY AN ALLEGEDLY DEFECTIVE UNSPECIFIED INVACARE WHEELCHAIR. NO OTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9000 SL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other