BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9614385-2006-00058

    MDR report key: 770620 · Received September 25, 2006

    Report

    Report Number
    9614385-2006-00058
    Event Type
    Injury
    Date Received
    September 25, 2006
    Product Code
    FWM
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION IDENTIFIED A SMALL BREACH APPROXIMATELY 2MM IN LENGTH WHICH IS LOCATED ON THE PERIPHERY OF THE DEVICE 9 ON THE 3 O'CLOCK POSITION (WHEN THE PRODUCT WAS HELD IN SUCH A POSITION THAT THE BRAND NAME WAS UPRIGHT AND HORIZONTAL). PRESSURE TESTING IDENTIFIED NO OTHER LEAKS OR BREACHES. 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 MANUFACTURE. THE BREACH IS NOT A MANUFACTURING FAULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1