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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
Medical Device Problem Code Insufficient Information (3190)
Health Effect - Clinical Codes Cyst(s) (1800); Dyspnea (1816); Pain (1994); Complaint, Ill-Defined (2331); Joint Swelling (2356); Heavier Menses (2666); No Code Available (3191)
Date of Event 08/05/2007
Type of Reportable Event Serious Injury
Event or Problem 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 Name
SMOOTH SALINE IMPLANT
Common Device Name
BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6773142
Report NumberMW5071413
Device Sequence Number1873063
Product Code FWM
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2003
Device Explanted Year2017
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 08/05/2007
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Model Number350-1650
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/05/2017
Patient Sequence Number1
Outcome Attributed to Adverse Event Disability;
Patient Age58 YR
Patient Weight66
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