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-410325
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Date of Event	08/30/2019
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 reported events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: capsular contracture, baker grade iv, and seroma.These are a known potential adverse events addressed in the product labeling.
Event or Problem Description
Healthcare professional reported a left side "seroma" and "capsular contracture," baker grade iv.The device was explanted.
Event or Problem Description
Healthcare professional reported a left side "seroma" and "capsular contracture," baker grade iv.The device was explanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified weight within specifications, deformation, crease fold.Cloudy and voids in the gel observed after autoclave cycle.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.

• 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: 9125511
• Report Number: 9617229-2019-14641
• Device Sequence Number: 2323527
• Product Code: FTR
• UDI-Device Identifier: 10888628003729
• UDI-Public: 10888628003729
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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: 01/13/2020
• Device Model Number: MX-410325
• Device Catalogue Number: MX-410325
• Device Lot Number: 2704906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 02/13/2020
• 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: 25 YR