BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE BREAST IMPLANT

    MDR report key: 3983559 · Received August 1, 2014

    Report

    Report Number
    MW5037625
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 31, 2014
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD LEFT BREAST RECONSTRUCTION AFTER BREAST CANCER SURGERY WITH A SALINE IMPLANT 4 YEARS AGO. SURGERY ON (B)(6) 2014 FOR A DEFLATED LEFT BREAST IMPLANT. THE DEFLATED SALINE IMPLANT WAS REMOVED AND REPLACED IT WITH A 363LF 450CC SERIAL # (B)(4). DURATION OF USE: 4 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451791 SALINE BREAST IMPLANT BREAST IMPLANT FWM ALLERGAN 363LF450

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention