MAUDE Adverse Event Report: SIENTRA INC SIENTRA SILICONE GEL BREAST IMPLANTS

Model Number	20621-695MP
Medical Device Problem Codes	Gel Leak (1267); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Seroma (2069); Rupture (2208); Breast Discomfort/Pain (4504); Swelling/ Edema (4577)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sientra complaint #: (b)(4).Medical device report in response to mdr report #: mw5155160.Patient age defaulted to "99" as no patient information was provided.No device information was provided by the initial reporter.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 and left-side late forming seroma.Patient reported symptoms: swelling, pain.

• Brand Name: SIENTRA SILICONE GEL BREAST IMPLANTS
• Common Device Name: SILICONE GEL BREAST IMPLANT
• Manufacturer (Section D): SIENTRA INC; 3333 michelson dr; suite 650; irvine CA 92612
• Manufacturer (Section G): SIENTRA INC; 3333 michelson dr; suite 650; irvine CA 92612
• Manufacturer Contact: denise dajles ; 8055628401
• MDR Report Key: 19692189
• Report Number: 1651189-2024-07232
• Device Sequence Number: 15205218
• Product Code: FTR
• UDI-Device Identifier: 00812790021604
• UDI-Public: 00812790021604
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P070004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2024

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: 20621-695MP
• Device Catalogue Number: 20621-XXXMP
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown