MAUDE Adverse Event Report: MENTOR BREAST IMPLANT

Lot Number 5746062

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

Patient Problems Gastritis (1874); Unspecified Infection (1930); Menstrual Irregularities (1959); Pain (1994); Palpitations (2467)

Event Date 10/20/2012

Event Type  Injury  

Event Description

Ongoing recurrent infections.Abnormal blood test results since 2012.Gi issues, pain.Menstrual period only twice or so a year (started in 2008 after implants).Palpitations.

• Brand Name: BREAST IMPLANT
• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6543640
• MDR Text Key: 74541124
• Report Number: MW5069555
• Device Sequence Number: 1
• Product Code: FWM
• 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: 05/02/2017
• 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 Lot Number: 5746062
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ALEVE; AMBIEN; ATIVAN; IMITREX; TRAMADOL; VITAMIN D
• Patient Outcome(s): Disability
• Patient Age: 48 YR
• Patient Weight: 58