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

Model Number	FX-410450
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported no complaint against the right side device.Healthcare professional later reported "palpable right breast mass," "pale polarizable material, suggestive of silicone," "breast tenderness," "discomfort in breasts," "lumps," "swellings," "hives." healthcare professional also reported "brain fog," and "unexplained illnesses" which are not device related.Device has been explanted.
Additional Manufacturer Narrative
Health effect f1905-device revision or replacement; f2203-imaging required.Date of occurrence (b)(6) 2021.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: ¿pale polarizable material, suggestive of silicone¿.
Event or Problem Description
Patient reported no complaint against the right side device.Healthcare professional later reported "palpable right breast mass," "pale polarizable material, suggestive of silicone," "breast tenderness," "discomfort in breasts," "lumps," "swellings," "hives." healthcare professional also reported "brain fog," and "unexplained illnesses" which are not device related.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: lump/nodule: unable to observe as it is a medical event not related to the device.Varied injuries-ndr: not applicable as the event is not related to the device.Pain: unable to observe as it is a medical event not related to the device.Rupture: no observed rupture on the device.Edema: unable to observe as it is a medical event not related to the device.Urticaria: unable to observe as it is a medical event not related to the device.Additional observations: crease fold, yellow particles and wear abrasion observed on the device.Deformation device observed on the device.

• 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
• 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: 16465088
• Report Number: 9617229-2023-02930
• Device Sequence Number: 5263066
• Product Code: FTR
• UDI-Device Identifier: 10888628002999
• UDI-Public: 10888628002999
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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: 04/11/2020
• Device Model Number: FX-410450
• Device Catalogue Number: FX-410450
• Device Lot Number: 2737324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2015
• 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: 70 KG
• Patient Ethnicity: Non Hispanic