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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANTS

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MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANTS Back to Search Results
Model Number 350-1460
Event Date 06/27/2016
Event Type  Injury  
Event Description

I developed reoccurring breast cellulitis due to 10 year old saline breast implants.

 
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Brand NameSMOOTH ROUND SPECTRUM SALINE BREAST IMPLANTS
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6260478
Report NumberMW5067289
Device Sequence Number2
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 01/15/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received01/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number350-1460
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? 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: 01/15/2017 Patient Sequence Number: 1
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