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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH SALINE IMPLANT BREAST IMPLANTS

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MENTOR SMOOTH SALINE IMPLANT BREAST IMPLANTS Back to Search Results
Model Number 350-1650
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.

 
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Brand NameSMOOTH SALINE IMPLANT
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6773142
Report NumberMW5071413
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 08/05/2007
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received08/05/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number350-1650
Device LOT Number256983
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/05/2017 Patient Sequence Number: 1
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