BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA RESPONSE

    MDR report key: 3140254 · Received May 24, 2013

    Report

    Report Number
    3005619970-2013-00007
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    May 13, 2013
    Manufacturer
    GETINGE SUZHOU CO. LTD.
    Product Code
    FNM
    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, INC. ON BEHALF OF THE MFR (GETINGE (SUZHOU) CO. LTD.). (B)(4). THE INFO CONTAINED WITHIN THIS REPORT IS BASED UPON THE INFO PROVIDED TO THE MFR BY REPS OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY. NO FURTHER DETAILS HAVE BEEN PROVIDED AT THIS TIME. ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232825 ALPHA RESPONSE PAC FNM GETINGE SUZHOU CO. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention