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

Catalog Number	115-150
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Failure of Implant (1924); Seroma (2069)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported rupture.Device was explanted.This relates to the left side.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Visual analysis of the photographs identified: rupture: no observed rupture on the device.No additional observations are performed.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.
Additional Manufacturer Narrative
Clarification to d.9.Returned to mfg on: the device has not been returned.See photo analysis previously reported in h.10.Additional, changed, and/or corrected data: b5, b6, h3, h6.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.
Event or Problem Description
Seroma-late was later reported based on ultrasound results.
Event or Problem Description
Healthcare professional reported, rupture.Seroma-late was later reported, based on ultrasound results.Device was explanted.This relates to the left side.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture: broken device observed assessed, as surgical damage.Missing shell assessed, as inconclusive.Seroma-late: unable to observe, as it is not related to the device.No other observations observed.No further actions are required, as no manufacturing issues are observed.
Event or Problem Description
Healthcare professional reported, rupture.Seroma-late was later, reported.Based on ultrasound results.Device was explanted.This relates to the left 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
• 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: 18256613
• Report Number: 9617229-2023-19752
• Device Sequence Number: 7116048
• 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: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/26/2024

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: 10/24/2020
• Device Catalogue Number: 115-150
• Device Lot Number: 2837129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 12/06/2023; 01/08/2024; 02/15/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 12/20/2023; 01/11/2024; 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2015
• 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 Age: 32 YR
• Patient Sex: Female