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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMALL ROUND SALINE FILLED MAMMARY PROSTHESIS BREAST IMPLANT

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MENTOR SMALL ROUND SALINE FILLED MAMMARY PROSTHESIS BREAST IMPLANT Back to Search Results
Model Number 350-1645
Event Date 04/28/2009
Event Type  Injury  
Event Description

Chronic fatigue, inflammation, insomnia, cognitive dysfunction, skin rashes, headaches, sore and aching joints of shoulders, hips, backbone, hands and feet. Anxiety, depression, and panic attacks, pain and/or burning sensation around implant and/or underarm, cold and discolored limbs, hands and feet, general chest discomfort. Shortness of breath, frequent urination, numbness/tingling sensations in upper and lower limbs, ear ringing, sudden food intolerance and allergies, vertigo.

 
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Brand NameSMALL ROUND SALINE FILLED MAMMARY PROSTHESIS
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6653071
Report NumberMW5070491
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation Patient
Report Date 06/18/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received06/18/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number350-1645
Device Catalogue Number259156
Device LOT Number261780
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: 06/18/2017 Patient Sequence Number: 1
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