BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2142618 · Received June 21, 2011

    Report

    Report Number
    1525712-2011-00284
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 20, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGED SERIOUS INJURY. MALFUNCTION ALLEGED. THE FRONT CASTER ALLEGEDLY BROKE, CAUSING THE CONSUMER TO FALL OUT OF THE CHAIR WITH NO INJURY. THE CONSUMER'S WEIGHT, AGE AND HEIGHT ARE UNKNOWN. THE MEDICAL DIAGNOSIS FOR USING THE CHAIR IS UNKNOWN. THE CONSUMER'S MEDICATION REGIMEN IS UNKNOWN. THE FLOORING, STREET, CURBING OR TERRAIN AT THE TIME OF THE ALLEGED INCIDENT IS UNKNOWN. THE SPEED OF THE DEVICE IS UNKNOWN. IT IS UNKNOWN IF THE DEVICE WAS ON AN INCLINE OR DECLINE. USAGE OF THE SEAT POSITIONING STRAP IS UNKNOWN.

    Description of Event or Problem · 1

    THE FRONT CASTER ALLEGEDLY BROKE, CAUSING THE CONSUMER TO FALL OUT OF THE CHAIR. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE ITI INVACARE TRSX5

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR