MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	MF-410580
Medical Device Problem Codes	Gel Leak (1267); Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/21/2020
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.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 side "rupture, pain sensation, hardening and enlargement".Device remains implanted.
Event or Problem Description
Patient reported right side "rupture, pain sensation, hardening and enlargement".Device remains implanted.
Event or Problem Description
Patient reported right side "rupture, pain sensation, hardening and enlargement".Healthcare professional later reported rupture.Healthcare professional later reported any creases, gel bleed and not ruptured.Device has been explanted.It has been determined that the event of rupture associated with this complaint did not occur.Therefore will be un-reported.
Additional Manufacturer Narrative
Continued h.6.Health effect - impact code: f2203.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ pain: unable to observe since it is not related to the device.¿ creases folding of implant: observed creases on the device.¿ visibility/palpability: unable to observe since it is not related to the device.¿ gel bleed: no observed.Additional observations: ¿ observed deformation on the device.No further actions are required as the device was implanted.
Event or Problem Description
Patient reported right side "rupture, pain sensation, hardening and enlargement".Healthcare professional later reported rupture.Healthcare professional later reported any creases, gel bleed and not ruptured.Device has been explanted.It has been determined that the event of rupture associated with this complaint did not occur.Therefore will be un-reported.

• Brand Name: STYLE 410 COHESIVE 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 10534172
• Report Number: 9617229-2020-14881
• Device Sequence Number: 1191921
• Product Code: FTR
• UDI-Device Identifier: 10888628003514
• UDI-Public: 10888628003514
• Combination Product (Y/N): N
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/06/2024

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: 11/01/2019
• Device Model Number: MF-410580
• Device Catalogue Number: MF-410580
• Device Lot Number: 2678895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 12/05/2023; 01/18/2024; 02/05/2024; 02/29/2024
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 12/19/2023; 01/24/2024; 02/13/2024; 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2014
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 61 KG