MAUDE Adverse Event Report: SIENTRA, INC. BREAST IMPLANT

Model Number 10521-655HP

Device Problems Material Discolored (1170); Dent in Material (2526)

Patient Problem No Code Available (3191)

Event Date 09/02/2015

Event Type  Injury  

Event Description

Patient had bilateral breast implants inserted (b)(6) 2015.Returned to surgery for revision on left breast.Clinically per surgeon stated, "breast had indentation, "concave" appearance.Upon removal implant was "white and cloudy" and "more dented than usual".Possible manufacture defect.

• Brand Name: BREAST IMPLANT
• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): SIENTRA, INC.; santa barbara CA 93117
• MDR Report Key: 5064117
• MDR Text Key: 25290216
• Report Number: MW5056031
• 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: Other Health Care Professional
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 10521-655HP
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR