MAUDE Adverse Event Report: MENTOR MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Fatigue (1849); Pain (1994)

Event Date 04/01/2008

Event Type  Injury  

Event Description

(b)(4). Chronic fatigue, body pain, brain fog, dry eyes.

• Brand Name: MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6533711
• MDR Text Key: 74054711
• Report Number: MW5069456
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 05/01/2017 Patient Sequence Number: 1