BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL CHAIR/TRANSPORT CHAIR

    MDR report key: 2902475 · Received January 8, 2013

    Report

    Report Number
    1531186-2013-00113
    Date Received
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    GOODBABY
    Product Code
    INM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). INJURY ALLEGED. MALFUNCTION ALLEGED. CUSTOMER SAYS THAT THREE RESIDENTS HAD THEIR LEG CUT. THE RESIDENTS LEG HAD FALLEN BETWEEN THE CUSHION AND THE SIDE PANEL AND A PIN STICKING OUT OF THE RELEASE LEVER CUT THEIR LEG. CUSTOMER WAS UNSURE OF THE EXACT CHAIRS THAT WERE INVOLVED IN THIS INCIDENT. NO MEDICAL ATTENTION WAS SOUGHT. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9432 MECHANICAL CHAIR/TRANSPORT CHAIR 890.3100 INM GOODBABY IH6074A/IH60

    Patients

    Seq Age Sex Outcome Treatment
    1 Other