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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Seroma (2069); Lymphoma (3263)
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 events of seroma and lymphoma are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this events.Reason for reoperation reported as seroma, inflammation, pain, and device removal due to product concern.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare provider reported left side seroma, inflammation, pain, and device removal due to product concern.Testing has been conducted for alcl however pathological markers have not been provided.Device has been explanted.
Additional Manufacturer Narrative
Previous medwatch submission noted suspected alcl.Upon review of received pathology reports, allergan medical safety determined that there is no malignancy.
Event or Problem Description
Testing has been conducted for alcl and no malignancy was found.

• 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: 9257138
• Report Number: 9617229-2019-18568
• Device Sequence Number: 2599732
• Product Code: FTR
• UDI-Device Identifier: 10888628002432
• UDI-Public: 10888628002432
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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: 09/13/2019
• Device Catalogue Number: 115-469
• Device Lot Number: 2661981
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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