MAUDE Adverse Event Report: MENTOR SILICONE BREAST IMPLANTS

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Anxiety (2328); Depression (2361); Numbness (2415); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 10/23/2016

Event Type  Injury  

Event Description

Have mentor breast implants.Brain fog, anxiety, depression, numbness, sore, fatigue, loss of ability.

• Brand Name: SILICONE BREAST IMPLANTS
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6812690
• MDR Text Key: 83480585
• Report Number: MW5071745
• 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: 08/21/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• 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): Disability
• Patient Age: 51 YR
• Patient Weight: 50