BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT BREAST COHESIVE I GEL PROFILE HI

    MDR report key: 5201575 · Received October 29, 2015

    Report

    Report Number
    MW5057680
    Event Type
    Injury
    Date Received
    October 29, 2015
    Date of Event
    October 22, 2015
    Report Date
    October 29, 2015
    Manufacturer
    J & J
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    BREAST CANCER, STATUS POST BILATERAL MASTECTOMY, RECONSTRUCTION RADIATION ON THE RIGHT, AND NOW HAS ASYMMETRY CAPSULAR CONTRACTURE BILATERALLY, WORSE ON THE RIGHT THAN THE LEFT. CHRONICALLY RUPTURED LEFT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720101 IMPLANT BREAST COHESIVE I GEL PROFILE HI IMPLANT BREAST COHESIVE I GEL PROFILE HI FTR J & J 350-6504BC LOG418269
    720102 IMPLANT BREAST COHESIVE I GEL PROFILE HI IMPLANT BREAST COHESIVE I GEL PROFILE HI FTR MENTOR 350-6504BC LOG418269

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention