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

Model Number	FF-410425
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	11/25/2019
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 initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Analysis of the returned device identified: deformation device, creases fold, yellow particles, crystalline, wear abrasion and overweight, however, a review of the weight reports generated during the manufacturing process is performed and all units were within specification.Therefore, the overweight observed during the additional analysis is not considered a workmanship (see the weight report attached).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.The event of capsular contracture 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: patient's concern with the product and capsular contracture, baker grade iii/iv.
Event or Problem Description
Healthcare professional reported a right side implant removal "out of concern with the device" and capsular contracture, baker grade iii-iv.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: 10942926
• Report Number: 9617229-2020-20357
• Device Sequence Number: 16688743
• Product Code: FTR
• UDI-Device Identifier: 10888628002685
• UDI-Public: 10888628002685
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2020

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: 12/26/2019
• Device Model Number: FF-410425
• Device Catalogue Number: FF-410425
• Device Lot Number: 2697257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 12/03/2020
• 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: 24 YR