MAUDE Adverse Event Report: SIENTRA BREAST IMPLANTS

Health Effect - Clinical Codes	Capsular Contracture (1761); Rash (2033); Depression (2361); Skin Inflammation (2443); Cognitive Changes (2551); No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
Breast implants, capsule contracture, fluid in breasts, rashes, brain fog, depression.I have had depression since the implants and very bad eczema, dry hair and skin and other health symptoms.

• Brand Name: BREAST IMPLANTS
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): SIENTRA
• MDR Report Key: 6972064
• Report Number: MW5072916
• Device Sequence Number: 15458151
• Product Code: FTR
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/22/2017
• 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?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 54 YR
• Patient Weight: 64