BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL CHAIR/TRANSPORT CHAIR

    MDR report key: 2905721 · Received January 9, 2013

    Report

    Report Number
    1531186-2013-00126
    Date Received
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    GOODBABY
    Product Code
    INM
    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

    ON (B)(6) - IT WAS REPORTED BY THE FACILITY DIRECTOR THAT THREE SIMILAR EVENTS HAPPENED TO THREE DIFFERENT PATIENTS, WHO HAD ONE OF THEIR LEGS SCRAPED BY A IH6074A/IH60 RECLINER. ALLEGEDLY, A LEG HAD FALLEN BETWEEN THE CUSHION AND THE SIDE PANEL WHERE A SHARP STEAL RIVET WAS STICKING OUT OF THE RELEASE LEVER. NO MEDICAL ATTENTION WAS SOUGHT, BECAUSE THE INJURIES WERE A SMALL SKIN TEAR ABOVE KNEE. NO INFORMATION REGARDING WHICH LEG, AND IF ALL THREE PATIENTS HAD THE SCRAPES ON THE SAME PORTION OF THE LEG. SHOULD WE RECEIVE ADDITIONAL INFORMATION ON THESE EVENTS, SUPPLEMENTAL MDR REPORTS WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12910 MECHANICAL CHAIR/TRANSPORT CHAIR 890.3100 INM GOODBABY IH6074A/IH60

    Patients

    Seq Age Sex Outcome Treatment
    1 Other