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

Catalog Number	TRLP-400
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Unspecified Infection (1930)
Date of Event	06/15/2018
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.The reported events are physiological complications.And analysis of the device generally does not assist allergan in determining a probable cause for these events.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: exposure and infection (late onset).
Event or Problem Description
Patient reported, left side "exchange from textured to smooth, due to concern with the product.Hashimoto's disease, asthma, no energy or strength and pain".Patient later reported, left side exposure, infection and swollen.Device remains implanted.
Event or Problem Description
Patient later reported left side rupture.Device has been explanted.
Event or Problem Description
Patient reported left side "exchange from textured to smooth due to concern with the product, hashimoto's disease, asthma, no energy or strength and pain." patient later reported left side exposure, infection, and swollen.Patient later reported left side rupture.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d.6b., h.6.

• 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 ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 19329198
• Report Number: 9617229-2024-0011328
• Device Sequence Number: 15189074
• Product Code: FTR
• UDI-Device Identifier: 10888628007949
• UDI-Public: 10888628007949
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2024

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: 02/28/2021
• Device Catalogue Number: TRLP-400
• Device Lot Number: 2890552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 10/11/2024; 11/06/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 10/30/2024; 11/12/2024
• Date Device Manufactured: 03/28/2016
• 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: 64 KG