MAUDE Adverse Event Report: SIENTRA SIENTRA BREAST IMPLANT

Model Number TEXTURED ROUND AUGMENTATION

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Rash (2033)

Event Date 10/28/2015

Event Type  Injury  

Event Description

I received sientra silicone breast implants on (b)(6) 2015.The serial number of the implant was (b)(4).A week after receiving the implants the implants i developed a bumpy rash covering the whole breast area that is red and purple in color.The symptoms are still persisting in the area and have not gotten any better.I saw the news about sientra's contamination in their factories and the (b)(6) medicines and healthcare products regulatory agency suspension of sales of sientra implants.I would like to be informed if the fda has any updates regarding possible contamination of the products in the u.S.And whether these rash symptoms are a byproduct of the implants.

• Brand Name: SIENTRA BREAST IMPLANT
• Type of Device: SIENTRA BREAST IMPLANT
• Manufacturer (Section D): SIENTRA
• MDR Report Key: 5201170
• MDR Text Key: 30461425
• Report Number: MW5057639
• 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: 10/29/2015

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
• Device Model Number: TEXTURED ROUND AUGMENTATION
• Device Catalogue Number: 20621-415HP
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 60