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

Catalog Number	TRX-400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swollen Lymph Nodes/Glands (4432)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "¿health has declined over the last few years with immune problems - not device related, underactive thyroid - not device related, low immune system - not device related, rheumatoid arthritis - not device related, swollen glands, lumps in armpits, permanently exhausted - not device related, concerns regarding bii and alcl.Patient is seeing a neuropsychologist - no answers from tests and has been signed off work for a long time.Patient reported lumps in the left.One breast is completely hard, the shape has changed¿¿ device remains implanted.This record relates to the left side.
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, anxiety, lump/nodule, and visibility/palpability.

• 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
• 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: 17769786
• Report Number: 9617229-2023-15018
• Device Sequence Number: 17801633
• Product Code: FTR
• UDI-Device Identifier: 10888628008502
• UDI-Public: 10888628008502
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2023

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 Catalogue Number: TRX-400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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