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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR BREAST IMPLANT SILICONE

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MENTOR BREAST IMPLANT SILICONE Back to Search Results
Catalog Number 350-5501BC
Event Date 07/29/2013
Event Type  Injury  
Event Description

Received mentor silicone breast implants on (b)(6) 2013. Have had several health issues since. Extreme fatigue, migraines, digestive issues, worsening depression/anxiety, brain fog, memory issues, hair loss, numbness and tingling in left arm and leg, breast pain, chest pain. Explanting asap.

 
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Brand NameBREAST IMPLANT SILICONE
Type of DeviceBREAST IMPLANT SILICONE
Manufacturer (Section D)
MENTOR
MDR Report Key6857663
Report NumberMW5072103
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 09/09/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received09/12/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue Number350-5501BC
Device LOT Number6514842
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: 09/12/2017 Patient Sequence Number: 1
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