MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 115 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	115-469
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	12/15/2016
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 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 reason for reoperation is capsular contracture, baker grade unknown, with pain, depression, tiredness, night sweats, no appetite, dry, cannot produce tears, lymphadenopathy.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Patient reported capsular contracture, baker grade unknown, pain, "lymph node issues," and "a lymph node under my right arm." patient additionally reported "night sweats," "no appetite," "depression to the point of thinking of committing suicide," "foggy brain," "dry, cannot produce tears," "tiredness," "anaphylactic shock" from "antibiotics and pain meds"; these events are not related to the device.Device remains implanted.This record is for the right side.

• Brand Name: STYLE 115 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: 8925662
• Report Number: 9617229-2019-10647
• Device Sequence Number: 253444
• Product Code: FTR
• UDI-Device Identifier: 10888628002432
• UDI-Public: 10888628002432
• Combination Product (Y/N): N
• Initial Reporter State: IA
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2020
• Device Catalogue Number: 115-469
• Device Lot Number: 2713476
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/23/2019
• 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: 47 YR