FDA Adverse Event Injury Summary report: N

MENTOR SMOOTH ROUND HIGH PROFILE GEL REF: 350-4004BC

MDR report key: 8470434 · Received March 29, 2019

Report

Report Number
MW5085407
Event Type
Injury
Date Received
March 29, 2019
Date of Event
January 17, 2019
Report Date
March 27, 2019
Manufacturer
MENTOR
Product Code
FTR
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
MO, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

MY MOST BOTHERSOME SYMPTOM WAS PAIN IN RIGHT SIDE (LOWER RIBCAGE, BACK, SHOULDER) THAT HAD BEEN WORSENING FOR A YEAR OR MORE AND WAS SEEKING CHIROPRACTIC CARE. IN (B)(6) 2018, I BEGAN NOTICING TENDERNESS AROUND/UNDER MY RIGHT BREAST, IT BECAME UNCOMFORTABLE ENOUGH THAT I STOPPED WEARING MY BRA ¿W¿ UNDERWIRE. IN (B)(6) 2019, I STARTED FEELING A BURNING IN MY CHEST WALL, 1ST ON THE RIGHT SIDE THEN SPREADING TO MY ENTIRE CHEST AREA, COUPLED WITH WHAT FELT LIKE EXTREME ANXIETY. NOT LONG AFTER, MY R BREAST BECAME HOT AND INFLAMED, AND I HAD TENDER NODULES (SWOLLEN AREA) UNDER R BREAST. I IMMEDIATELY MADE AN APPOINTMENT TO SEE M BREAST SPECIALIST, FEARING MY CANCER HAD RETURNED. I AM NOW ALSO, DEALING WITH EXHAUSTION, EXTREME MUSCLE FATIGUE AND JOINT PAIN. UP TO THIS POINT, I HAVE BEEN VERY ACTIVE, WORKING OUT SEVERAL TIMES A WEEK, ENJOYING CYCLING, HIKING ETC. I AM NO LONGER ABLE TO WORK OUT AND HAVE VERY LITTLE ENERGY TO KEEP UP WITH MY DAY TO DAY ACTIVITIES. I FEEL LIKE AN 80 YEAR OLD WOMAN. MY CONCENTRATION IS ALSO LOW. I HAVE PERSISTENT WORRYING, PAIN ALL AROUND MY RIGHT RIB CAGE, OCCASIONAL SEARING PAIN IN MY CHEST. PERSISTENT BURNING AND ACHING IN MY RIGHT ARM AND ON THE RIGHT SIDE OF MY HEAD. I'VE DEVELOPED A LUMP IN MY RIGHT ARM. VISIBLE AND SORE TO THE TOUCH. CT SHOWS SUSPICIOUS SPOTS ON MY RIGHT LUNG. LOOKING BACK, I HAVE HAD A VARIETY OF SYMPTOMS THAT I HAD NOT LINKED TO IMPLANTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
260355 MENTOR SMOOTH ROUND HIGH PROFILE GEL REF: 350-4004BC PROSTHESIS, BREAST NON INFLATABLE INTERNAL FTR MENTOR 350-4004BC 6624366
260356 MENTOR SMOOTH ROUND HIGH PROFILE GEL REF: 350-4004BC PROSTHESIS, BREAST NON INFLATABLE INTERNAL FTR 350-4004BC

Patients

Seq Age Sex Outcome Treatment
1 54 YR Required Intervention