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

Model Number	20676-XXXE
Health Effect - Clinical Codes	Seroma (2069); Anaplastic Large Cell Lymphoma (3264)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient diagnosed with late-forming seroma.Left-side device tested positive for bia-alcl.

• Brand Name: SIENTRA OPUS SILICONE GEL BREAST IMPLANT
• Common Device Name: SIENTRA SILICONE GEL BREAST IMPLANT
• Manufacturer (Section D): SIENTRA, INC.; 420 s fairview avenue; suite 200; santa barbara CA 93117
• MDR Report Key: 8595874
• Report Number: 1651189-2019-00140
• Device Sequence Number: 2293276
• Product Code: FTR
• UDI-Device Identifier: 00812790022045
• UDI-Public: 00812790022045
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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: No Information
• Device Expiration Date: 11/01/2016
• Device Model Number: 20676-XXXE
• Device Catalogue Number: 20676-450E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/09/2019
• 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: 40 YR