BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1085167 · Received June 4, 2008

    Report

    Report Number
    3003768277-2008-00008
    Event Type
    Other
    Date Received
    June 4, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LNH
    PMA / PMN Number
    K001796
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CONCLUSIONS: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA. NOTE: THE INDICATED IMPORTER HAS REC'D FDA EXEMPTION TO SUBMIT ONE FDA FORM 3500A TO SATISFY BOTH THE IMPORTER AND MFR FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * LNH PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. * *

    Patients

    Seq Age Sex Outcome Treatment
    1