BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPO

    MDR report key: 2669896 · Received July 18, 2012

    Report

    Report Number
    9681684-2012-00048
    Event Type
    Injury
    Date Received
    July 18, 2012
    Date of Event
    June 13, 2012
    Report Date
    June 20, 2012
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY (B)(6) ON BEHALF OF THE MANUFACTURER ARJOHUNTLEIGH (B)(4) MANUFACTURER COMPLAINT NUMBER: (B)(4). PLEASE NOTE THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE (B)(4). AS OF (B)(6) 2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH MAGOG AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #(B)(4). THE DEVICE WAS INSPECTED ON-SITE BY A REPRESENTATIVE OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    WHILE THE PATIENT WAS TRANSFERRED FROM THE BATH TO THE FLOOR LIFT, THE PATIENT AND FLOOR LIFT FELL DOWN. THE PATIENT SUSTAINED A CONTUSION AT THE FACE, WOUND AT THE CHEEKBONE AND ABDOMINAL HEMATOMA. THE PATIENT WENT TO E.R. AND WAS HOSPITALIZED, BUT NO ADDITIONAL DETAILS WERE RELEASED ABOUT A POSSIBLE TREATMENT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPO MANUFCTURED FLOOR PASSIVE LIFT FSA ARJOHUNTLEIGH MAGOG INC. KPA5000

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization