MAUDE Adverse Event Report: SIENTRA BREAST IMPLANTS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Capsular Contracture (1761); Rash (2033); Depression (2361); Skin Inflammation (2443); Cognitive Changes (2551); No Code Available (3191)

Event Type  Injury  

Event 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
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): SIENTRA
• MDR Report Key: 6972064
• MDR Text Key: 90170096
• Report Number: MW5072916
• Device Sequence Number: 1
• Product Code: FTR
• 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: 10/22/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 10/24/2017 Patient Sequence Number: 1