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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH ROUND MODERATE PLUS PROFILE GEM IMPLANT BREAST IMPLANT

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MENTOR SMOOTH ROUND MODERATE PLUS PROFILE GEM IMPLANT BREAST IMPLANT Back to Search Results
Model Number 350-3251BC
Event Date 08/12/2013
Event Type  Injury  
Event Description

Began with pain in joints/muscles of the neck, led to other infections and weakened immune system, followed by growing pain in joints and extreme fatigue.

 
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Brand NameSMOOTH ROUND MODERATE PLUS PROFILE GEM IMPLANT
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6459767
Report NumberMW5068891
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 04/04/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received04/04/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number350-3251BC
Device LOT Number5947419
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: 04/04/2017 Patient Sequence Number: 1
Treatment
OTC MEDS: MULTIVITAMIN
PROBIOTIC
RX MEDS: NA
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