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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH ROUND MODERATE PLUS PROFILE GEL IMPLANTS

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MENTOR SMOOTH ROUND MODERATE PLUS PROFILE GEL IMPLANTS Back to Search Results
Model Number REF 350-3501BC
Event Date 07/21/2009
Event Type  Injury  
Event Description

On (b)(6) 2009 is the date i had surgery to have implants. Within 6 months of that time frame, i started to have medical concerns, which were unusual for me. Previous to implants i was on medication for thyroid issues, but nothing else and was in very good health. Over time, the number of health concerns increased or became increasingly worse. Over the past 3-4 years, the intensity of issues has become severe. Yet, when i seek the care of specialists, few are able to set a solid diagnosis and i also received clashing diagnosis when seeking second opinions. What they are clear about is that i have autoimmune/inflammatory issues in addition to memory issues/brain fog. These issues impact daily. I had mris to check for issues with neck- diagnosed at first as herniated discs but then as arthritis. Due to memory issues and based on disclosure of history only, one doctor diagnosed dementia. Another said i was "an interesting case" as tests for memory mostly showed fairly bad short term memory. Mris of brain to check for memory related causes were inconclusive. Additional xrays and a great deal of blood work to determine arthritis issues which seem to be taking over my body (was diagnosed as rheumatoid arthritis, but medications have not helped reduce the issues it causes. Pain is intense, particularly in the mornings or after sitting for a while. Fatigue was addressed with a suggestion to get more sleep. Breast pain near site of implants was dismissed and then appeased by suggestion to take both vitamin e and evening primrose oils (neither helped reduce pain/discomfort). Hugs hurt. Skin issues were addressed with various creams/meds, none which resulted in improvement.

 
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Brand NameSMOOTH ROUND MODERATE PLUS PROFILE GEL IMPLANTS
Type of DeviceSMOOTH ROUND MODERATE PLUS PROFILE GEL IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6584693
Report NumberMW5069928
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 05/21/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received05/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberREF 350-3501BC
Device LOT Number5905331
Was Device Available For Evaluation? Yes
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: 05/21/2017 Patient Sequence Number: 1
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