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

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 350-4504C 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