MAUDE Adverse Event Report: MENTOR BREAST IMPLANT

Model Number 350-2375

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Tinnitus (2103); Anxiety (2328); Arthralgia (2355); Depression (2361); Respiratory Tract Infection (2420); Palpitations (2467)

Event Type  Injury  

Event Description

I have mentor breast implants that were placed in (b)(6)2007.I have had numerous health issues over the years since the implants but this winter, things got worse.Ongoing unexplained upper respiratory infections (went to sinus specialist and despite numerous tests she could not find cause), body rash, large itchy painful welts on my breasts, heart palpitations, anxiety and depression, joint pain, ringing in my ears, etc.

• Brand Name: BREAST IMPLANT
• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6662959
• MDR Text Key: 78356831
• Report Number: MW5070578
• Device Sequence Number: 1
• Product Code: FTR
• 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: 06/21/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 350-2375
• Device Lot Number: 5688105
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 61