BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENCORE

    MDR report key: 2571127 · Received May 3, 2012

    Report

    Report Number
    3004468271-2012-00013
    Event Type
    Death
    Date Received
    May 3, 2012
    Date of Event
    April 13, 2012
    Report Date
    April 13, 2012
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. ((B)(4)) ON BEHALF OF THE MANUFACTURER MEDIBO MEDICAL PRODUCTS (B)(4). (B)(4). PLEASE BE ADVISED THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED BY THE ORIGINAL MANUFACTURER OF THIS DEVICE MEDIBO MEDICAL PRODUCTS (B)(4), WHICH HAS CEASED MANUFACTURING AS OF (B)(4) 2011. EFFECTIVE (B)(4) 2011, ANY MEDICAL DEVICES THAT WERE FORMALLY PRODUCED BY MEDIBO WILL BE MANUFACTURED BY OTHER FACILITIES WITHIN ARJO (B)(4) AND WILL BE LABELED TO REFLECT THIS: ADDITIONALLY, ANY REPORTABLE COMPLAINTS WILL BE HANDLED BY ARJOHUNTLEIGH (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION. THE EVALUATION OF THE DEVICE TO DATE HAS BEEN CARRIED OUT BY A REPRESENTATIVE OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MANUFACTURER.

    Description of Event or Problem · 1

    INITIALLY IT WAS REPORTED (INFORMAL NOTIFICATION): "A PATIENT USING AN ENCORE FOR WALKING EXERCISE FELL AND WAS IMPALED ON THE 'PROACTIVE KNEEPAD BRACKET'. THE PATIENT IS REPORTED TO LATER HAVE DIED." FROM CONVERSATION WITH (B)(6), IT WOULD APPEAR PATIENT WAS NOT USING ENCORE, BUT FELL ON IT FROM ANOTHER DEVICE. FURTHER INVESTIGATION IS NEEDED. THE ENCORE DEVICE IS SIMILAR TO SARA PLUS WHICH IS DISTRIBUTED ON THE U.S MARKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE ACTIVE FLOOR LIFTS FSA MEDIBO MEDICAL PRODUCTS NV

    Patients

    Seq Age Sex Outcome Treatment
    1 Death