BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPO

    MDR report key: 3350353 · Received September 4, 2013

    Report

    Report Number
    9681684-2013-00073
    Event Type
    Injury
    Date Received
    September 4, 2013
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MFR ARJOHUNTLEIGH MAGOG INC ON BEHALF OF THE IMPORTER (B)(4). PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MFG AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE ARJO (B)(4). AS OF (B)(4) 2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MFR. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH MAGOG. THE DEVICE WAS INSPECTED ON-SITE BY A REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    REFERENCE IMPORTER NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439612 TEMPO FSA ARJO MED AB LTD

    Patients

    Seq Age Sex Outcome Treatment
    1