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

Model Number	MX-410550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Seroma (2069)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted beyond 30 calendar days from allergan¿s receipt due to a system error preventing allergan from submitting reports via emdr.The system error has been resolved at this time and an investigation has been initiated into this occurrence.A review of the device history record has been completed.No deviations or non-conformances noted.Further investigation: with the information collected during the investigation, there is enough evidence to support that the device was manufactured under controlled conditions in accordance with allergan procedures.Seal strength results were acceptable.Environmental monitoring results were found to be acceptable and they confirmed that there was not an adverse impact on environmental conditions, device quality or performance.Given the fact that the cause of the infection cannot be specifically associated to costa rica manufacturing process, and there is not an adverse trend for this type of event no corrective action is deemed necessary at this time.The events of infection and seroma-late are physiological complications 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: "infected seroma" and exchange due to concern with textured product.
Event or Problem Description
Healthcare professional reported left side "infected seroma" and exchange due to concern with textured product.Device has been explanted.
Additional Manufacturer Narrative
Device photo evaluation: visual analysis of the photographs identified a device with an extended opening.
Event or Problem Description
Healthcare professional reported left side "infected seroma" and exchange due to concern with textured product.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; CS
• MDR Report Key: 9947822
• Report Number: 9617229-2020-05314
• Device Sequence Number: 3329470
• Product Code: FTR
• UDI-Device Identifier: 10888628003774
• UDI-Public: 10888628003774
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

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: 08/12/2021
• Device Model Number: MX-410550
• Device Catalogue Number: MX-410550
• Device Lot Number: 2961871
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 04/09/2021
• 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
• Patient Age: 50 YR
• Patient Weight: 76