BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRELLE INSPIRATION COHESIVE BREAST IMPLANT

    MDR report key: 16204664 · Received January 18, 2023

    Report

    Report Number
    MW5114372
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    December 23, 2022
    Report Date
    January 15, 2023
    Manufacturer
    ALLERGAN SALES, LLC.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY IMPLANTS ARE FLIPPING - THE BACK OF THE IMPLANT IS NOW AT THE FRONT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393961 NATRELLE INSPIRATION COHESIVE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN SALES, LLC. SCX-700
    393962 NATRELLE INSPIRATION COHESIVE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN SALES, LLC. SCX-700

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Hospitalization CALCIUM| CLONIDINE| DESIPRAMINE| EXEMESTANE| GLUCOSAMINE CHONDROITIN| HYDRALAZINE| HYOSCYAMINE| METOPROLOL| OMEPRAZOLE| VITAMIN D