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

Model Number	20621-XXXHPU
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	08/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sientra complaint #: (b)(4).Investigational device [ide], no expiration date or date of manufacture available.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.
Event or Problem Description
Left-side suspected rupture.

• 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: 15301785
• Report Number: 1651189-2022-03056
• Device Sequence Number: 2468253
• Product Code: FTR
• UDI-Device Identifier: 00812790021567
• UDI-Public: 00812790021567
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P070004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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: 20621-XXXHPU
• Device Catalogue Number: 20621-485MP
• Device Lot Number: 1589880
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/22/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 08/26/2022
• 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 Age: 50 YR
• Patient Sex: Female