BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX GEL IMPLANTS COHESIVE II

    MDR report key: 9540607 · Received January 2, 2020

    Report

    Report Number
    MW5092003
    Event Type
    Injury
    Date Received
    January 2, 2020
    Date of Event
    October 31, 2019
    Report Date
    December 31, 2019
    Manufacturer
    MENTOR
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GB
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I BELIEVE I HAVE BREAST IMPLANT ILLNESS. I HAVE DEVELOPED FRUCTOSE MALABSORPTION/BS ALONG WITH CONSTANT FATIGUE AND EXHAUSTION AND HAIR LOSS. FAD SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4552 MENTOR SILTEX GEL IMPLANTS COHESIVE II PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR MENTOR
    4553 MENTOR SILTEX GEL IMPLANTS COHESIVE II PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR MENTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Disability