MAUDE Adverse Event Report: SIENTRA SIENTRA BREAST IMPLANTS

Health Effect - Clinical Codes	Fatigue (1849); Hair Loss (1877); Memory Loss/Impairment (1958); Blurred Vision (2137); Complaint, Ill-Defined (2331); Joint Disorder (2373); Sleep Dysfunction (2517); Cognitive Changes (2551)
Date of Event	09/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Breast implants, sientra making me ill.Hair loss, fatigue, memory loss, brain fog, blurry vision, joint pain, and sleep disturbance.

• Brand Name: SIENTRA BREAST IMPLANTS
• Common Device Name: SIENTRA BREAST IMPLANTS
• Manufacturer (Section D): SIENTRA
• MDR Report Key: 6232513
• Report Number: MW5067097
• Device Sequence Number: 929663
• Product Code: FTR
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/05/2017
• 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: 01/05/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 34 YR
• Patient Weight: 54