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-410370
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	08/15/2018
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" 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.
Event or Problem Description
Patient reported "developed fluid around the right breast implant".Patient additionally reported "a month and a half later they took them out, the incision would not close, and had an infection for a year"; these events are not device related.This record is for the right side.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: 9950250
• Report Number: 9617229-2020-06229
• Device Sequence Number: 14267271
• Product Code: FTR
• UDI-Device Identifier: 10888628003736
• UDI-Public: 10888628003736
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 10/14/2021
• Device Model Number: MX-410370
• Device Catalogue Number: MX-410370
• Device Lot Number: 2988347
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 04/10/2020
• 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: 33 YR