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

Model Number	115-401
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
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 and seroma are 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: capsular contracture baker grade iv, seroma (not tested yet), and exchange from textured to smooth due to product concern.
Event or Problem Description
Healthcare professional reported left side capsular contracture baker grade iv, seroma (not tested yet), and exchange from textured to smooth due to product concern.The device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h6.Reason for reoperation: capsular contracture baker grade iv, seroma (not tested yet), exchange from textured to smooth due to product concern, and rupture.
Event or Problem Description
Healthcare professional initially reported left side capsular contracture baker grade iii and exchange from textured to smooth due to product concern.Later, healthcare professional reported capsular contracture baker grade iv and seroma (not tested yet).Later, healthcare professional reported rupture.Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture: observed crease smooth opening on radius assessed as fold flaw opening.Anxiety-product/procedure: unable to confirm as it is a medical event not related to the device.Seroma: unable to confirm as it is a medical event not related to the device.Capsular contracture: unable to confirm as it is a medical event not related to the device.Additional observations: crease fold observed.Wear abrasion observed.No further actions are required as the device was implanted.
Event or Problem Description
Healthcare professional later reported exchange from textured to smooth due to product concern, capsular contracture baker grade iv, seroma, and rupture.Device has been explanted.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 16404181
• Report Number: 9617229-2023-01942
• Device Sequence Number: 5742917
• Product Code: FTR
• UDI-Device Identifier: 10888628002418
• UDI-Public: 10888628002418
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2023

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: 08/16/2020
• Device Model Number: 115-401
• Device Catalogue Number: 115-401
• Device Lot Number: 2805819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 03/31/2023; 05/29/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 04/17/2023; 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 52 KG