BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA 3000

    MDR report key: 3080673 · Received April 12, 2013

    Report

    Report Number
    3007420694-2013-00019
    Event Type
    Injury
    Date Received
    April 12, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (B)(4). ON BEHALF OF THE (B)(4). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFG'S INVESTIGATION.

    Description of Event or Problem · 1

    PLEASE REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159081 SARA 3000 ACTIVE FLOOR LIFTS FSA ARJOHUNTLEIGH POLSKA SP. ZO.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention