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

Model Number	115-222
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Failure of Implant (1924); Seroma (2069)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: rupture.
Event or Problem Description
Patient reported right rupture.The device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of seroma-late is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation: seroma-late.
Event or Problem Description
Healthcare professional later reported seroma-late.The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ rupture: observed an opening sharp assessed as unidentified (tear) opening (shell thickness was within specification).¿ seroma-late: unable to confirm as it is a medical event not related to the device.¿ wrinkling: unable to confirm as it is a medical event not related to the device.¿ anxiety-product/procedure: unable to confirm as it is a medical event not related to the device.¿ inflammation/irritation: unable to confirm as it is a medical event not related to the device.Additional observations: ¿ crease fold observed in the device.No further actions are required as the device was implanted.
Event or Problem Description
Patient reported right rupture.The events of "bag wrinkling, fluid collection, capsule formation" via us report and "few inflammatory cells" via cytology and "bia-alcl examination conducted before replacement surgery" were later reported.Device was explanted and replaced.

• 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: 16894707
• Report Number: 9617229-2023-07889
• Device Sequence Number: 14344402
• Product Code: FTR
• UDI-Device Identifier: 10888628002340
• UDI-Public: 10888628002340
• 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: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2023
• 2 Devices were Involved in the Event: 1 2

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: 05/09/2020
• Device Model Number: 115-222
• Device Catalogue Number: 115-222
• Device Lot Number: 2752975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 06/15/2023; 08/10/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 07/07/2023; 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2015
• 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