MAUDE Adverse Event Report: MENTOR SILICONE GEL IMPLANTS; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED

Model Number 35045048C

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/13/2013

Event Type  Injury  

Event Description

Had breast implants put in and have had failing health since.Just came across the breast implant illness.

• Brand Name: SILICONE GEL IMPLANTS
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6922108
• MDR Text Key: 88862939
• Report Number: MW5072634
• 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: 10/04/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/04/2017
• Device Model Number: 35045048C
• Device Lot Number: 6558914
• 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): Hospitalization; Other; Disability
• Patient Age: 41 YR
• Patient Weight: 109