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

Model Number 10512

Device Problem Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Reported rupture of silicone gel-filled breast implant.

• Brand Name: SIENTRA SILICONE GEL BREAST IMPLANT
• Manufacturer (Section D): SIENTRA, INC; santa barbara CA
• Manufacturer (Section G): SILIMED-INDUSTRIALDE IMPLANTES LTDA; rua figueiredo rocha; 374 - figario geral; io de janeiro 2124 0; BR 21240
• Manufacturer Contact: joann kuhne ; 6769 hollister ave.; suite 201; santa barbara, CA 93117 ; 8056798879
• MDR Report Key: 3373424
• MDR Text Key: 3934816
• Report Number: 1651189-2013-00026
• 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: 09/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Model Number: 10512
• Device Catalogue Number: 10512-380MP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• 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