BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRELLE INSPIRA (LEFT BREAST)

    MDR report key: 19309815 · Received May 13, 2024

    Report

    Report Number
    MW5154785
    Event Type
    Injury
    Date Received
    May 13, 2024
    Date of Event
    April 24, 2024
    Report Date
    May 9, 2024
    Manufacturer
    ALLERGAN SALES, LLC
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SEVERE PAIN, BURNING IN MY BREAST FOR ABOUT 2 YEARS. MRI (MAGNETIC RESONANCE IMAGING) FINALLY DONE AND DETECTED BOTH 7YR OLD IMPLANTS ARE RUPTURED. REFERENCE REPORT: MW5154786.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546737 NATRELLE INSPIRA (LEFT BREAST) PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN SALES, LLC TRM-330

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other ESTRADIOL.| LEXAPRO.| MAGNESIUM.| PROGESTERONE.| SYNTHROID.