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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR BREAST IMPLANT

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MENTOR BREAST IMPLANT Back to Search Results
Model Number 350-4504C 450CC
Event Date 05/04/2017
Event Type  Injury  
Event Description

Mastectomy reconstruction revision for deformed reconstructed left breast. Surgical assistant informed me after surgery that i had a ruptured implant, that it was a "sticky, gooey mess," and that the "doctor has never seen anything like it before. ".

 
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Brand NameBREAST IMPLANT
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6872000
Report NumberMW5072183
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/14/2017
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? Yes
Device Operator NO INFORMATION
Device MODEL Number350-4504C 450CC
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: 09/15/2017 Patient Sequence Number: 1
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