BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 757182 · Received August 14, 2006

    Report

    Report Number
    9614385-2006-00049
    Event Type
    Injury
    Date Received
    August 14, 2006
    Manufacturer
    *
    Product Code
    FWM
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION IDENTIFIED A SMALL TEAR ON THE VALVE - SHELL INTERFACE WHICH IS LOCATED ON THE 6 O'CLOCK POSITION (WHEN THE PRODUCT WAS HELD IN SUCH A POSITION THAT THE BRAND NAME WAS UPRIGHT AND HORIZONTAL). PRESSURE TESTING COULD NOT BE COMPLETED DUE TO THE SIZE AND POSITION OF THE BREACH. MICROSCOPIC EXAMINATION (X10) OF THE TEAR IDENTIFIED RAGGED EDGES WHICH IS INDICATIVE OF EXCESSIVE FORCE HAVING BEING USED. THE PRODUCT MET ALL MANUFACTURING AND QUALITY SPECIFICATIONS POST MANUFACTURE. THE TEAR 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 *