MAUDE Adverse Event Report: MENTOR SMOOTH SALINE IMPLANT; BREAST IMPLANTS

Model Number 350-1650

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Dyspnea (1816); Pain (1994); Complaint, Ill-Defined (2331); Joint Swelling (2356); Heavier Menses (2666); No Code Available (3191)

Event Date 08/05/2007

Event Type  Injury  

Event Description

Heart problem.Ekg done due to breathing difficulty and swollen ankles.Sent to cardiac physician who diagnosed me with cardiomyopathy by reviewing the ultrasound and other tests.No family history, no alcohol induced cardiomyopathy.Since then i have had to take coreg cr 20 mg to help my heart.And since then i have had a multitude of unexplainable joint aches and pains.I have also had surgeries for those joint problems.Antecubital trigger thumb release, frozen shoulder release, chiropractic manipulation for several back problem etc.Other problems have been, brain fog, sad, allergies consistently, heavy periods at age (b)(6) and had to have cryoablation, cystic breasts with one biopsy (neg) and several aspirations of cysts, and finally the most recent, feeling of helplessness because of all my aching joints.My ana was positive right before explant (b)(6)2017.

• Brand Name: SMOOTH SALINE IMPLANT
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6773142
• MDR Text Key: 82135182
• Report Number: MW5071413
• Device Sequence Number: 2
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/05/2007
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 350-1650
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Weight: 66