BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 216071 · Received March 18, 1999

    Report

    Report Number
    216071
    Event Type
    Injury
    Date Received
    March 18, 1999
    Date of Event
    March 8, 1999
    Report Date
    March 18, 1999
    Manufacturer
    GRAHAM-FIELD TEMCO, INC
    Product Code
    FRJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE A CERTIFIED NURSING ASSISTANT WAS TRANSFERRING PT OUT OF CHAIR (GERICHAIR) TO BED, PT'S HAND JERKED AND FELL BETWEEN THE SEAT AND SIDE OF CHAIR AT THE SAME TIME. THE CERTIFIED NURSING ASSISTANT WAS FOLDING THE CHAIR TO A SITTING POSITION. THE PT SUFFERED SEVERE LACERATIONS TO THE TWO DIGITS OF HIS LEFT HAND (THE MIDDLE FINGER AND THE RING FINGER). HE WAS ADMITTED TO THE HOSPITAL WHERE SURGICAL INTERVENTION WAS NEEDED. THE CHAIR APPEARS TO BE FUNCTIONING NORMALLY BUT FACILITY QUESTIONS A DESIGN FLAW OR THE ADDITION OF A SAFETY COVER TO THE HINGE AREA UNDER THE SEAT & NEXT TO THE SIDE OF THE CHAIR. SUPPLIES HAS REFUSED SEVERAL REQUESTS TO COME AND CERTIFIY THAT THE EQUIPMENT IS FUNCTIONING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK GERI CHAIR FRJ GRAHAM-FIELD TEMCO, INC TEMCO 5000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| O