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-410495
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swollen Lymph Nodes/Glands (4432)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The event of lymphadenopathy is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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: lymphadenopathy.
Event or Problem Description
Healthcare professional reported left internal mammary lymphadenopathy with silicone on biopsy and "a single pink nodule" which is non device related.The device has been explanted and replaced.
Event or Problem Description
Healthcare professional reported via sus voluntary event report "suspected rupture" and "device malfunction-that is, the device did not do what it was supposed to do.".
Additional Manufacturer Narrative
In response to fda report number: (b)(4).
Event or Problem Description
Healthcare professional reported left internal mammary lymphadenopathy with silicone on biopsy and "a single pink nodule" which is non device related.Healthcare professional reported via sus voluntary event report "suspected rupture" and "device malfunction-that is, the device did not do what it was supposed to do." the device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture: no observed were openings on the device.Lymphadenopathy: 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.Anxiety-product/procedure: unable to observe as it is a medical event not related to the device.Additional observations: observed deformation on the device.Observed wear abrasion on the device.Observed creases on the device.No further actions are required as the device was implanted.A review of the device history record has been completed.No deviations or non-conformances noted.

• 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: 16632369
• Report Number: 9617229-2023-04561
• Device Sequence Number: 5577455
• Product Code: FTR
• UDI-Device Identifier: 10888628003002
• UDI-Public: 10888628003002
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2023

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: 08/03/2021
• Device Model Number: FX-410495
• Device Catalogue Number: FX-410495
• Device Lot Number: 2955318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 03/29/2023; 06/23/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/18/2023; 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2016
• 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: 34 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic