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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR TEXTURED SILICONE IMPLANT

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MENTOR TEXTURED SILICONE IMPLANT Back to Search Results
Event Date 07/21/2017
Event Type  Injury  
Event Description

Bia alcl - swelling - around implant - need aspiration.

 
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Brand NameTEXTURED SILICONE IMPLANT
Type of DeviceTEXTURED SILICONE IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6871650
Report NumberMW5072162
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
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: 09/15/2017 Patient Sequence Number: 1
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