BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 347602 · Received August 14, 2001

    Report

    Report Number
    MW1022650
    Date Received
    August 14, 2001
    Manufacturer
    MENTOR INC
    Product Code
    FWM
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT BORN WITH POLAND'S SYNDROME. HAS UNDERGONE A SERIES OF OPERATIONS (3 SINCE 1995) FOR PLACEMENT OF AN IMPLANT FOR SYMMETRY AND RECONSTRUCTIVE PURPOSES. ON A YEARLY BASIS FOR LAST 3 YRS PT HAS HAD THE IMPLANT DEFLATE. PT UNDERWENT REMOVAL OF INTACT BUT DEFLATED IMPLANT. AUGMENTED ON RIGHT WITH SILICONE IMPLANT. DEFLATED IMPLANT CLEANED, DECONTAMINATED AND RETURNED TO MENTOR CORP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36855 * SALINE MAMMARY IMPLANT FWM MENTOR INC UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR