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

Model Number	MF-410335
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: ""fluid build up in chest cavity", "wears a suit to assist in reducing fluid build up', "suit/implants cause itching" and exchange of textured breast implants due to the patient¿s concern with the product."" allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.
Event or Problem Description
Patient reported right side fluid build up in chest cavity", "wears a suit to assist in reducing fluid build up', "suit/implants cause itching" and exchange of textured breast implants due to the patient¿s concern with the product.Patient additionally reported being "really sick for 3 years." device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h6.
Event or Problem Description
Device has been explanted.

• 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
• MDR Report Key: 11613178
• Report Number: 9617229-2021-06284
• Device Sequence Number: 19580295
• Product Code: FTR
• UDI-Device Identifier: 10888628003460
• UDI-Public: 10888628003460
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: 12/22/2020
• Device Model Number: MF-410335
• Device Catalogue Number: MF-410335
• Device Lot Number: 2857664
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 06/08/2021
• 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