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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS

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MENTOR BREAST IMPLANTS Back to Search Results
Lot Number 6646221
Event Date 01/01/2014
Event Type  Injury  
Event Description

Within a year of receiving mentor silicone high profile breast implants my health had declined tremendously. Some of the symptoms are, joint pain, muscle pain, blurry vision, ringing in the ears, hair loss, ibs, chronic fatigue, memory loss.

 
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Brand NameBREAST IMPLANTS
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6560080
Report NumberMW5069699
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 05/10/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received05/10/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device LOT Number6646221
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: 05/10/2017 Patient Sequence Number: 1
Treatment
BIO IDENTICAL HORMONES
MULTIPLE VITAMINS
OTC MEDS: PROBIOTICS
RX MEDS: NEURONTIN
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