MAUDE Adverse Event Report: SIENTRA, INC. SIENTRA SILICONE GEL BREAST IMPLANT

Model Number 10512-600MP (RIGHT SIDE)

Device Problems Folded (2630); Material Deformation (2976)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 03/18/2013

Event Type  Injury  

Event Description

Implant has folded inside my body creating significant ripping, deformity and pain.

• Brand Name: SIENTRA SILICONE GEL BREAST IMPLANT
• Type of Device: SILICONE GEL BREAST IMPLANT
• Manufacturer (Section D): SIENTRA, INC.
• MDR Report Key: 4114520
• MDR Text Key: 4939472
• Report Number: MW5038298
• 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: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 10512-600MP (RIGHT SIDE)
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 65