MAUDE Adverse Event Report: MENTOR TEXTURED SILICONE IMPLANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling (2091)

Event Date 07/21/2017

Event Type  Injury  

Event Description

I have mentor breast implants for reconstruction from cancer 2015.In a matter of 48 hours - one breast swelled and i went to see my plastic surgeon.

• Brand Name: TEXTURED SILICONE IMPLANT
• Type of Device: TEXTURED SILICONE IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6773348
• MDR Text Key: 82162187
• Report Number: MW5071419
• Device Sequence Number: 1
• Product Code: FTR
• 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: 08/04/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 55 YR
• Patient Weight: 61