BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL LIFT - II TRANSFER CHAIR

    MDR report key: 753631 · Received August 18, 2006

    Report

    Report Number
    3023859-2006-00001
    Event Type
    Injury
    Date Received
    August 18, 2006
    Date of Event
    June 16, 2006
    Report Date
    August 16, 2006
    Manufacturer
    WY'EAST MEDICAL CORP.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS PERFORMED ON THE DEVICE BY DISTRIBUTOR'S FIELD SERVICE REPRESENTATIVE. SEE ATTACHED INCIDENT EVALUATION FORM. IT WAS REPORTED BY THE DISTRIBUTOR REPRESENTATIVE WHO PERFORMED THE INCIDENT REVIEW ON SITE, THAT ALL PERSONNEL INTERVIEWED AT THE FACILITY AGREED THAT THE CHAIR COULD NOT HAVE CAUSED THE INJURIES INCURRED BY THE RESIDENT.

    Description of Event or Problem · 1

    LONG-TERM RESIDENT WITH COMPLICATIONS FROM A STROKE WAS PLACED IN A CHAIR FOR AN EXTENDED PERIOD OF TIME THAT WAS MANUFACTURED BY OUR COMPANY. RESIDENT WAS FOUND TO HAVE A LACERATION ON FINGER WHEN CAREGIVERS RETURNED. SOME BLOOD WAS FOUND ON ONLY THE MATTRESS PAD OF THE CHAIR. RESIDENT WAS TAKEN TO HOSPITAL EMERGENCY ROOM FOR TREATMENT AND FINGER WAS AMPUTATED TO THE FIRST KNUCKLE. SEE ATTACHED COMPLETED INCIDENT EVALUATION FORM FROM COMPANY, DATED 07/26/2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL LIFT - II TRANSFER CHAIR TRANSFER CHAIR FSA WY'EAST MEDICAL CORP. TOTAL LIFT - II *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization