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

Model Number	SCX-495
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Unspecified Infection (1930)
Date of Event	06/06/2022
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 events of infection and exposure 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: "[patient] developed a right periprosthetic infection with device exposure this week necessitating implant removal".
Event or Problem Description
Healthcare professional reported "[patient] developed a right periprosthetic infection with device exposure this week necessitating implant removal".The device has been explanted.
Additional Manufacturer Narrative
Correction to h6: previously reported code of e1906 was reported in error as the noted infection was indicated by healthcare professional to not be device related.
Event or Problem Description
Allergan medical safety has deemed the reported infection not related to the device.
Event or Problem Description
Physician reported right side "device exposure." the event of the patient "developed a right periprosthetic infection" is not device related.Device status was explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a2.

• Brand Name: INSPIRA SMOOTH 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: 14948777
• Report Number: 9617229-2022-11252
• Device Sequence Number: 12010761
• Product Code: FTR
• UDI-Device Identifier: 10888628030336
• UDI-Public: 10888628030336
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2022

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: 02/10/2026
• Device Model Number: SCX-495
• Device Catalogue Number: SCX-495
• Device Lot Number: 3501520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 07/07/2022; 11/29/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 07/07/2022; 12/20/2022
• Date Device Manufactured: 03/10/2021
• 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: 32 YR
• Patient Sex: Female