BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODERATE PLUS PROFILE COHESIVE III

    MDR report key: 8847002 · Received July 29, 2019

    Report

    Report Number
    MW5088565
    Event Type
    Injury
    Date Received
    July 29, 2019
    Date of Event
    January 5, 2018
    Report Date
    July 25, 2019
    Manufacturer
    MENTOR
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NZ
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BREAST IMPLANTS MENTOR COHESIVE GEL TEXTURED AFTER DOUBLE MASTECTOMY FOR BREAST CANCER PREVENTATIVE RASH, ACHING JOINTS, SWOLLEN GLANDS, MOUTH ULCERS HEADACHES, SORE NECK, HEAD, BRAIN FOG. I'VE HAD PROBLEMS FOR YEARS NOW. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628857 MODERATE PLUS PROFILE COHESIVE III PROSTHESIS, BREAST, NON-INFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR 6866638
    628858 MODERATE PLUS PROFILE COHESIVE III PROSTHESIS, BREAST, NON-INFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR 6884512

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Disability