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

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

Patient Problems Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Pain (1994); Malaise (2359)

Event Date 01/01/2007

Event Type  Injury  

Event Description

(b)(4). I actually started feeling ill within a year of my implants. I have been diagnosed with fibromyalgia, uterine cancer, ovarian cancer, chronic fatigue, food allergies, joint pain etc. None of which i had before implants.

• Brand Name: MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7215051
• MDR Text Key: 98084584
• Report Number: MW5074780
• 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: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• 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: 01/24/2018 Patient Sequence Number: 1