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

Catalog Number	SSL-290
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 infection (early-onset) 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: infection (early-onset).
Event or Problem Description
Patient reports left side rupture.Healthcare professional later reported left side implant exchange with no complaint against the device.Patient later reported went septic after surgery.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5., b.6., h.6.
Event or Problem Description
The device has been discarded.

• Brand Name: INSPIRA SMOOTH 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: 21446070
• Report Number: 9617229-2022-17177
• Device Sequence Number: 15276354
• Product Code: FTR
• UDI-Device Identifier: 10888628032545
• UDI-Public: 10888628032545
• 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: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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: 09/23/2025
• Device Catalogue Number: SSL-290
• Device Lot Number: 3518145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 02/26/2025
• Date Device Manufactured: 10/23/2020
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 88 KG