BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE BREAST IMPLANT

    MDR report key: 20578164 · Received October 30, 2024

    Report

    Report Number
    MW5161950
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 23, 2024
    Manufacturer
    SIENTA INC. / TIGER AESTHETICS MEDICAL
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MRI DISCOVERED EXTRACAPSULAR AND INTRACAPSULAR RUPTURE OF SIENTRA SMOOTH ROUND SILICONE BREAST IMPLANT CAUSING PAIN IN LEFT CHEST AND ARMPIT. MODEL: 10521-495HP, SN: (B)(6). NO SMOKING, NO ALCOHOL USE, NORMAL BMI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065650 SILICONE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR SIENTA INC. / TIGER AESTHETICS MEDICAL 10521-495HP

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Disability| O| R AZELAIC ACID| ESTRADIOL 0.25MG| PROGESTERONE 200MG| RHOFADE TOPICAL| SIENTRA SMOOTH ROUND BREAST IMPLANTS| TESTOSTERONE 2MG| VIT D + K2| VYVANSE 30MG