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

Catalog Number	TRF-295
Medical Device Problem Codes	No Apparent Adverse Event (3189); Migration (4003)
Health Effect - Clinical Codes	Swollen Lymph Nodes/Glands (4432); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported, left side "axillary lymphadenopathy.Which is likely, due to silicone.The device remains implanted.
Additional Manufacturer Narrative
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 & silicone migration.
Additional Manufacturer Narrative
Based on additional information received, from the physician.There is no complaint reported, for the left side.Hence, unreporting the previously reported event of lymphadenopathy.
Event or Problem Description
Based on additional information received, from the physician.There is no complaint reported for the left side.Hence, unreporting the previously reported event of lymphadenopathy.

• Brand Name: INSPIRA TEXTURED 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; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 19057153
• Report Number: 9617229-2024-06016
• Device Sequence Number: 20341090
• Product Code: FTR
• UDI-Device Identifier: 10888628008274
• UDI-Public: 10888628008274
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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 Catalogue Number: TRF-295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 04/13/2024
• Initial Report FDA Received Date: 04/07/2024
• Supplement Report FDA Received Date: 05/08/2024
• 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