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

Model Number 20621HP

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 04/12/2014

Event Type  Injury  

Event Description

Silicone gel breast implant - patient reported rippling visible on right side.Device removed and replaced.

• Brand Name: SIENTRA SILICONE GEL-FILLED BREAST IMPLANT
• Manufacturer (Section D): SIENTRA, INC; santa barbara CA
• Manufacturer (Section G): SILIMED, INDUSTRIA DE IMPLANTES LTDA; rua figueiredo rocha; 374 - figario geral; rio de janeiro TX 2124 0; BR 21240
• Manufacturer Contact: joann kuhne ; 6769 hollister ave ste 201; santa barbara, CA 93117 ; 8056798879
• MDR Report Key: 3815022
• MDR Text Key: 19969680
• Report Number: 1651189-2014-00017
• 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: 05/07/2014

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: 11/01/2016
• Device Model Number: 20621HP
• Device Catalogue Number: 20621-505HP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2014
• Initial Date FDA Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 28 YR
• Patient Weight: 54