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

Model Number	10621-XXXMP
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	05/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient diagnosed with bilateral capsular contracture, baker grade iv.This report is for the left-side device.

• Brand Name: SIENTRA OPUS SILICONE GEL BREAST IMPLANT
• Common Device Name: SILICONE GEL BREAST IMPLANT
• Manufacturer (Section D): SIENTRA, INC.; 420 s fairview ave.; suite 200; santa barbara CA 93117
• MDR Report Key: 8671098
• Report Number: 1651189-2019-00194
• Device Sequence Number: 18893003
• Product Code: FTR
• UDI-Device Identifier: 00812790020973
• UDI-Public: 00812790020973
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P070004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: 10621-XXXMP
• Device Catalogue Number: 10621-305MP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR