BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARA STEDY

    MDR report key: 3192578 · Received June 19, 2013

    Report

    Report Number
    9681684-2013-00055
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) BY THE MANUFACTURER ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE IMPORTER (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

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279384 SARA STEDY FSA ARJOHUNTLEIGH MAGOG INC.

    Patients

    Seq Age Sex Outcome Treatment
    1