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MENTOR BREAST IMPLANT Back to Search Results
Model Number 350-4504C 450CC
Device Problem Material Rupture (1546)
Patient Problem No Code Available (3191)
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 Name
Type of Device
Manufacturer (Section D)
MDR Report Key6872000
MDR Text Key86588827
Report NumberMW5072183
Device Sequence Number1
Product Code FWM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
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
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Weight64