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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS 3000 ROUND HILE PROFILE

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MENTOR BREAST IMPLANTS 3000 ROUND HILE PROFILE Back to Search Results
Catalog Number REF 350-3380
Event Date 12/01/2005
Event Type  Injury  
Event Description

I began having rheumatoid symptoms - inflammation, huge knots popping up in various joints, pain on level 10. Had vertigo for over a year, tinnitus, debilitating fatigue, depression, anxiety hair loss, weight gain and loss for no apparent reason, heart palpitations and chest pain, rashes, shingles x3 over the past year.

 
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Brand NameBREAST IMPLANTS 3000 ROUND HILE PROFILE
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6893883
Report NumberMW5072419
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/24/2017
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received09/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue NumberREF 350-3380
Device LOT Number244699
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

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