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

Model Number	20645-XXXMP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	04/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A foreign body reaction.
Additional Manufacturer Narrative
Sientra complaint# (b)(4).At this time, the suspect device has not been returned for evaluation.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: SIENTRA OPUS SILICONE GEL BREAST IMPLANT
• Common Device Name: SILICONE GEL BREAST IMPLANT
• Manufacturer (Section D): SIENTRA INC.; 420 s fairview suite 200; santa barbara CA 93117
• Manufacturer (Section G): SIENTRA INC.; 420 s fairview suite 200; santa barbara CA 93117
• Manufacturer Contact: denise dajles ; 8055623500
• MDR Report Key: 15084751
• Report Number: 1651189-2022-02877
• Device Sequence Number: 5102071
• Product Code: FTR
• UDI-Device Identifier: 00819409020867
• UDI-Public: 00819409020867
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P070004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2022

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 Model Number: 20645-XXXMP
• Device Catalogue Number: 20645-350MP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 07/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female