BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRELLE BREAST IMPLANTS

    MDR report key: 8392277 · Received March 5, 2019

    Report

    Report Number
    MW5084640
    Event Type
    Injury
    Date Received
    March 5, 2019
    Date of Event
    January 1, 2016
    Report Date
    March 4, 2019
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER BREAST IMPLANT SURGERY EXPERIENCED SEVERE BREAST PAIN, CAPSULAR CONTRACTURE BAKER 4, SMALL FIBER NEUROPATHY, MAST CELL ACTIVATION SYNDROME, HEDS, POTS, THORACIC SCOLIOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186211 NATRELLE BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN SRF
    186212 NATRELLE BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN SRF

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| S