BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE TEXTURED GUMMY BEAR BREAST IMPLANTS RIGHT

    MDR report key: 21168414 · Received January 16, 2025

    Report

    Report Number
    MW5164809
    Event Type
    Injury
    Date Received
    January 16, 2025
    Date of Event
    January 1, 2016
    Report Date
    January 12, 2025
    Manufacturer
    SIENTRA, INC./TIGER AESTHETICS MEDICAL
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR MW5164809 ON JANUARY 30, 2025 TO CHANGE THE NAME OF THE MANUFACTURER.

    Description of Event or Problem · 0

    I HAVE DEVELOPED CHRONIC CHOLINERGIC URTICARIA / AKA SWEAT ALLERGY SINCE MY IMPLANTS WERE PLACED IN 2013. I AM NOW ON 3 ALLERGY MEDICATIONS FOR THE CHRONIC HIVES. IF I STOP THE MEDICATION, I HAVE HOT FLUSHING / NOT HOT FLASHING WHERE I SWEAT. I WILL BE ON ALLERGY MEDICATIONS FOR LIFE OR POSSIBLY SOONER IF I AM EXPLANTED. REFERENCE REPORT: MW5164808.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111253 SILICONE TEXTURED GUMMY BEAR BREAST IMPLANTS RIGHT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR SIENTRA, INC./TIGER AESTHETICS MEDICAL 20646-200RB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other DOTTI PROGESTERONE | FAMOTADINE | FISH OIL | JOINT SUPPLEMENT WITH TURNERIC| LEVOCETERIZINE | MONTELUKAST | STRATERRA| VITAMIN B, FISH OIL| VITAMIN C| VITAMIN D| WELLBUTRIN