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

Catalog Number	SCM-520
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	04/01/2025
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 event of capsular contracture 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: capsular contracture baker grade iv.
Event or Problem Description
Sales representative reported warranty claim for capsular contracture baker grade unknown.Later patient reported right side implant that never dropped and is hard and a possible capsular contracture with baker grade unknown.Healthcare professional reported right side that never dropped, is hard and capsular contracture baker grade iv.The device remains implanted.
Event or Problem Description
Patient reported warranty claim for capsular contracture baker grade unknown.Patient later reported right side implant that never dropped and is hard and a possible capsular contracture with baker grade unknown.Healthcare professional additionally reported right side that never dropped, is hard and capsular contracture baker grade iv.Healthcare professional later reported capsular contracture baker grade iii.The device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a2, a4, a5, a6, b3, b5, d4, e1, g2, h3, h4.

• 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; 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: 22090282
• Report Number: 9617229-2025-08690
• Device Sequence Number: 17871765
• Product Code: FTR
• UDI-Device Identifier: 10888628029958
• UDI-Public: (01)10888628029958(10)1222063(11)240118(17)281218
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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 Catalogue Number: SCM-520
• Device Lot Number: 1222063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2024
• 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 Age: 60 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White