MAUDE Adverse Event Report: SIENTRA SIENTRA BREAST IMPLANTS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 11/04/2014

Event Type  Injury  

Event Description

After two months of switching saline to seintra "gummies", i have become very sick.

• Brand Name: SIENTRA BREAST IMPLANTS
• Type of Device: SIENTRA BREAST IMPLANTS
• Manufacturer (Section D): SIENTRA
• MDR Report Key: 5324496
• MDR Text Key: 34321940
• Report Number: MW5058703
• Device Sequence Number: 1
• Product Code: FTR
• 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: 12/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 61