BEUDAMED
    FDA Adverse Event Death Summary report: N

    9613846-2007-00001

    MDR report key: 820061 · Received January 29, 2007

    Report

    Report Number
    9613846-2007-00001
    Event Type
    Death
    Date Received
    January 29, 2007
    Product Code
    ESW
    PMA / PMN Number
    K971509
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    NOVATECH SA HAS ONLY THE COPY OF THE LETTER OF DR AS INFO CONCERNING THIS EVENT. AT 01/29/07 NOVATECH SA DOES NOT KNOW YET WHICH PROSTHESIS IS CONCERNED IN THIS MEDICAL REPORT; NOVATECH SA WILL SUBMIT FOLLOW-UP REPORTS WHEN ADDITIONAL DATA WILL BE AVAILABLE. HOWEVER, NOVATECH SA TRACED ALL THE BATCHES OF PROSTHESIS SOLD TO THE HENRY FORD HOSP IN 2006 AND INSPECTED THE MANUFACTURING DATA: NO ABNORMALITY WAS OBSERVED. FURTHERMORE, WE DID NOT RECEIVE ANY OTHER COMPLAINT CONCERNING THESE BATCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESW

    Patients

    Seq Age Sex Outcome Treatment
    1