MAUDE Adverse Event Report: MENTOR BREAST IMPLANT

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.".

• Brand Name: BREAST IMPLANT
• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6872000
• MDR Text Key: 86588827
• Report Number: MW5072183
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

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