MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	FF-410740
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information contained in this report was previously submitted through psr on 22/jan/2019.A review of the device history record has been completed.No deviations or non-conformances noted.The event of seroma-late is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: seroma-late, lymphadenopathy, inflammation/irritation.
Event or Problem Description
Patient reported right side "reactive fluid around the breast," "a few lymph nodes 6 millimeters in size on breast," "inflammation and swelling." also reported "swelling of the neck" which is not device related.Device has been explanted.Events have not been confirmed with physician.
Event or Problem Description
Patient reported right side "reactive fluid", "a few lymph nodes 6 millimeters in size on the right breast", " and "doctor suspects "lymphoma." healthcare professional additionally reported swelling of the neck on the right side" and "wound hematoma" not related to the device.Device has been explanted.
Additional Manufacturer Narrative
Clarification for b5 - according to the pathology reports, there is no malignancy.
Event or Problem Description
Patient reported right side "reactive fluid", "a few lymph nodes 6 millimeters in size on the right breast", " and "doctor suspects "lymphoma." healthcare professional additionally reported swelling of the neck on the right side" and "wound hematoma" not related to the device.Device has been explanted.According to lab report - negative for malignant cells.

• Brand Name: STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 10891375
• Report Number: 9617229-2020-18973
• Device Sequence Number: 3284779
• Product Code: FTR
• UDI-Device Identifier: 10888628002739
• UDI-Public: 10888628002739
• Combination Product (Y/N): N
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2023

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: 03/20/2020
• Device Model Number: FF-410740
• Device Catalogue Number: FF-410740
• Device Lot Number: 2731770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 12/09/2020; 03/02/2023
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/06/2021; 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2015
• 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: 45 YR
• Patient Sex: Female