MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 168 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	168-210
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.The reasons for reoperation are capsular contracture, baker grade "iii/iv" and patient concern with the product.
Event or Problem Description
A healthcare professional reported left side capsular contracture, baker grade "iii/iv"and bilateral exchange from textured to smooth breast implants due to the patient¿s concern with the product.Device remains implanted.

• Brand Name: STYLE 168 SALINE FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9587935
• Report Number: 9617229-2019-23498
• Device Sequence Number: 19457866
• Product Code: FWM
• UDI-Device Identifier: 10888628000780
• UDI-Public: 10888628000780
• Combination Product (Y/N): N
• Initial Reporter State: ID
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2020

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: 09/21/2018
• Device Catalogue Number: 168-210
• Device Lot Number: 2665943
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/14/2020
• 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: 70 YR