BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 967123 · Received June 21, 2007

    Report

    Report Number
    9614385-2006-00040
    Event Type
    Injury
    Date Received
    June 21, 2007
    Product Code
    FWM
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINAL SURGERY WAS PERFORMED BY DR IN 1998 USING HUTCHISON HSH 0375CC SALINE-FILLED IMPLANTS, WHICH WERE FILLED TO A VOLUME OF 0400CC, WHICH IS WITHIN THE MAXIMUM FILL VOLUME LIMIT. PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY IN 2006. THE IMPLANTS WERE REPLACED WITH MENTOR DEVICES. VISUAL INSPECTION IDENTIFIED A FOLD FLAW APPROX 4MM IN LENGTH, WHICH ENDS IN A SPLIT APPROX 0.5MM IN LENGTH. PRESSURE TESTING IDENTIFIED NO OTHER LEAKS OR BREACHES. MICROSCOPIC EXAMINATION (X10) OF THE FOLD FLAW IDENTIFIED SIGNS OF FATIGUE AROUND THE SPLIT ON THE FOLD FLAW. THE PRODUCT HISTORY SHEET CONFIRMED THE PRODUCT MET ALL QUALITY CRITERIA. FOLD FLAWS ARE NOT MANUFACTURING FAULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1