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-410255
Date of Event	06/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.
Event or Problem Description
Patient reported an unknown side of "experiencing symptoms" and "experiencing persistent pain over the past 3 months." healthcare provider additionally reported left side pain, swelling and "small amount of fluid but nothing significant." this record will be for the left side.Device remains implanted.

• 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: 10740991
• Report Number: 9617229-2020-14787
• Device Sequence Number: 11559593
• Product Code: FTR
• UDI-Device Identifier: 10888628003446
• UDI-Public: 10888628003446
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

1 Device 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: 09/17/2019
• Device Model Number: MF-410255
• Device Catalogue Number: MF-410255
• Device Lot Number: 2664084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No