MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Anxiety (2328); Arthralgia (2355); Depression (2361); Sleep Dysfunction (2517); Cognitive Changes (2551)
Date of Event	05/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Symptoms: fatigue, endocrine issues, depression, panic attacks, insomnia, joint pain and cognitive dysfunction.

• Brand Name: BREAST IMPLANTS
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6553864
• Report Number: MW5069638
• Device Sequence Number: 14330063
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 05/06/2017
• 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
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5-HTP.; ADRENAL; CHASTE TREE; GLUTHATHIONE; IRON; MACA ROOT; OTC MEDS: MULTIVITAMIN; RX MEDS: NA; VITAMIN D
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 24 YR
• Patient Weight: 64