MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 15 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	15-659
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information contained in this report was previously submitted through psr on 10/15/2018.A review of the device history record has been completed.No deviations or non-conformances noted.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.The reason for reoperation: capsular contracture, baker grade iv.Device evaluation: visual analysis of the returned device identified: deformation, wear abrasion, white particles and creases.Bubbles, voids and cloudy after autoclave disinfection process in the gel.A weight test of the device was verified and the device was within specification.Based on the device analysis the final assessment is: no issues found related with the manufacturing.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported a right-side capsular contracture, baker grade iv.Device has been explanted.

• Brand Name: STYLE 15 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: 8794393
• Report Number: 9617229-2019-08238
• Device Sequence Number: 2043372
• Product Code: FTR
• UDI-Device Identifier: 10888628001558
• UDI-Public: 10888628001558
• Combination Product (Y/N): N
• Initial Reporter State: NH
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

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: 06/23/2020
• Device Catalogue Number: 15-659
• Device Lot Number: 2781291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/16/2019
• 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: 36 YR