MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS

Lot Number 267381

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Pain (1994); Swollen Lymph Nodes (2093); Arthralgia (2355); Confusion/ Disorientation (2553)

Event Date 09/01/2016

Event Type  Injury  

Event Description

Bilateral breast pain from breast implants.Experiencing joint pain, chronic fatigue, brain fog, swollen lymph nodes after mammogram.

• Brand Name: BREAST IMPLANTS
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6879290
• MDR Text Key: 86976495
• Report Number: MW5072220
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• 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: 09/17/2017
• 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: Health Professional
• Device Lot Number: 267381
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 41 YR
• Patient Weight: 73