MAUDE Adverse Event Report: MENTOR BREAST IMPLANT

Model Number	350-4504C 450CC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/04/2017
Type of Reportable Event	Serious Injury
Event or Problem 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.".

• Brand Name: BREAST IMPLANT
• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6872000
• Report Number: MW5072183
• Device Sequence Number: 663872
• Product Code: FWM
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 350-4504C 450CC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Weight: 64