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

Model Number 10521

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2014

Event Type  Injury  

Event Description

Silicone gel breast implant - mri indicated device rupture.Device removed and replaced with identical device.

• Brand Name: SIENTRA SILICONE GEL-FILLED BREAST IMPLANT
• Manufacturer (Section D): SIENTRA, INC; santa barbara CA
• Manufacturer (Section G): SILIMED - INDUSTRIA DE IMPLANTES LTDA; 374 - figario geral; fua figueiredo rocha; rio de janeiro 2124 0; BR 21240
• Manufacturer Contact: joann kuhne ; 6769 hollister ave., suite 201; santa barbara, CA 93117 ; 8056798879
• MDR Report Key: 3852982
• MDR Text Key: 4654808
• Report Number: 1651189-2014-00020
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Model Number: 10521
• Device Catalogue Number: 10521-335HP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 05/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR