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

Catalog Number	SRM-600
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Foreign Body Reaction (1868)
Date of Event	09/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported right side capsular contracture baker grade unknown and "posed breast implant, breast hypoplasia." device has been explanted.
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 events of exposure and capsular contracture are physiological complications and analysis of the device generally do 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 capsular contracture baker grade unknown.

• 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 ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18007954
• Report Number: 9617229-2023-17486
• Device Sequence Number: 7389186
• Product Code: FTR
• UDI-Device Identifier: 10888628007185
• UDI-Public: 10888628007185
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2023

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 Expiration Date: 07/11/2026
• Device Catalogue Number: SRM-600
• Device Lot Number: 3540576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 66 KG