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

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Lot Number: 5746062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 05/02/2017 Patient Sequence Number: 1

Treatment

ALEVE; AMBIEN; ATIVAN; IMITREX; TRAMADOL; VITAMIN D