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

Model Number	115-150
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported no complaint against the right device.Physician later reported right side rupture.The events of "isoechoic fluid collection between implant bag and capsule", "focal detachment of implant c several folding of implant bag", "sever capsule thickening c irregular implant contour" and "double capsule c contracture" baker grade unknown were reported via us report.The event of "several cysts and hypoechoic nodules" is not device related.Device was explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The events of capsular contracture and seroma are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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 unknown, rupture, seroma late, crease folding, double capsule, malposition lump nodule, cyst.
Event or Problem Description
Patient reported no complaint against the right device.Physician later reported right side rupture.The events of "isoechoic fluid collection between implant bag and capsule", "focal detachment of implant c several folding of implant bag", "sever capsule thickening c irregular implant contour" and "double capsule c contracture" baker grade unknown were reported via us report.The event of "several cysts and hypoechoic nodules" is not device related.Device was explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture: one opening observed on posterior side assessed as fold flaw opening.Seroma-late: unable to observe as it is a medical event not related to the device.Capsular contracture: unable to observe as it is a medical event not related to the device.Double capsule: unable to observe as it is a medical event not related to the device.Crease/folding of implant: creases were observed.Malposition: unable to observe as it is a medical event not related to the device.Lump/nodule-ndr: not applicable as the event is not related to the device cyst-ndr: not applicable as the event is not related to the device.Additional observations: creases were observed.Wear abrasion observed.Blank particles observed on the surface of the shell.Stress marks observed.

• 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: 15562067
• Report Number: 9617229-2022-18212
• Device Sequence Number: 20255094
• Product Code: FTR
• UDI-Device Identifier: 10888628002302
• UDI-Public: 10888628002302
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2023

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: 04/20/2020
• Device Model Number: 115-150
• Device Catalogue Number: 115-150
• Device Lot Number: 2744219
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 01/02/2023
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2015
• 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: 55 KG
• Patient Race: Asian