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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR BREAST IMPLANT

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MENTOR MENTOR BREAST IMPLANT Back to Search Results
Model Number 350-2325
Event Date 01/04/2008
Event Type  Injury  
Event Description

Mentor saline breast implants caused hashimotos and sjogrens auto immune. Hair loss, fatigue, brain fog, weight gain.

 
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Brand NameMENTOR BREAST IMPLANT
Type of DeviceMENTOR BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6224791
Report NumberMW5067035
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation Patient
Report Date 01/02/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received01/02/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number350-2325
Device LOT Number5689013
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? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/02/2017 Patient Sequence Number: 1
Treatment
MILK THISTLE
MULTI VITAMIN
VITAMIN D
VITAMIN K2
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