BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9614385-2006-00047

    MDR report key: 746155 · Received August 9, 2006

    Report

    Report Number
    9614385-2006-00047
    Event Type
    Injury
    Date Received
    August 9, 2006
    Product Code
    FWM
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION: VISUAL INSPECTION IDENTIFIED A BREACH WHICH STARTS ON THE PERIPHERY THAT MOVED ALONG THE ANTERIOR SHELL THAT WENT AROUND THE VALVE COMPONENT AREA AND BACK TOWARDS THE PERIPHERY WHERE IT STOPPED APPROXIMATELY 20MM FROM THE PERIPHERY'S EDGE. THE APPROXIMATE TOTAL LENGTH OF THIS BREACH IS 190MM (WHEN THE PRODUCT WAS HELD IN SUCH A POSITION THAT THE BRAND NAME WAS UPRIGHT AND HORIZONTAL). PRODUCT INSPECTION: PRESSURE TESTING COULD NOT BE COMPLETED DUE TO THE SIZE AND POSITION OF THE BREACH. MICROSCOPIC EXAMINATION (X10) OF THE BREACH IDENTIFIED A CLEAR INITIATION POINT AND WELL DEFINED EDGES WHICH ARE INDICATIVE OF MECHANICAL TRAUMA. THE PRODUCT MET ALL MANUFACTURING AND QUALITY SPECIFICATIONS POST MFR. CONCLUSIONS: THE BREACH WAS NOT A MANUFACTURING FAULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1