BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREATMENT RECLINER

    MDR report key: 3100243 · Received May 8, 2013

    Report

    Report Number
    0001831750-2013-04174
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 11, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FRK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLARIFICATION OF SERIOUS INJURY: POSSIBLE STRAIN OF BICEPS FEMORIS MUSCLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY CUSTOMER THAT WHEN THE RECLINER FOOT WAS RAISED, IT JERKED UP, ALLEGEDLY CAUSING PATIENT TO HYPEREXTEND THEIR LEFT KNEE. THE CUSTOMER REPORTED THAT THE PATIENT WAS NOT ALL THE WAY IN THE CHAIR WHEN THEY PULLED THE HANDLE. THE CHAIR BACK CAME UP AND FOOT SECTION CAME OUT HITTING THE PATIENT IN THE BACK OF THE KNEES AND BACK. THE CUSTOMER HAS ALLEGED THAT THE PATIENT REQUIRED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200823 TREATMENT RECLINER CHAIR, EXAMINATION AND TREATMENT FRK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1