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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH SALINE IMPLANTS

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MENTOR SMOOTH SALINE IMPLANTS Back to Search Results
Lot Number 6425763
Event Date 06/01/2015
Event Type  Injury  
Event Description

In 2011 at the age of (b)(6) i had a breast augmentation using mentor 3500cc smooth saline implants. Over the next 6 years i began to experience various symptoms such as daily headaches, insomnia, anxiety, and brain fog that i just wrote off at the time. By the summer of 2015 my health had took a turn for the worse. I became bedridden and only made attempts to get up to see another doctor to just get no answers to my sudden health decline that felt like i was dying some days.

 
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Brand NameSMOOTH SALINE IMPLANTS
Type of DeviceSMOOTH SALINE IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6456465
Report NumberMW5068879
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 03/31/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received03/31/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device LOT Number6425763
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: 03/31/2017 Patient Sequence Number: 1
Treatment
ADDERALL
D3
EPSOM SALT SOAKS
MAGNESIUM
OTC MEDS: NIACIN
PROBIOTIC
RX MEDS: EFFEXOR
VALIUM
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