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

Model Number	SRM-195
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	04/08/2021
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 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 iii/iv.
Event or Problem Description
Healthcare professional reported a right side capsular contracture, baker grade iii/iv.Device remains implanted.
Event or Problem Description
The device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5 , d.6b , g.2 , h.6.
Event or Problem Description
Healthcare professional reported a right side capsular contracture, baker grade iii/iv.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a4, d9, h3, h6.
Additional Manufacturer Narrative
A visual analysis of the returned device identified: weight to the spec, crease flat.Cloudy and bubbles were observed after autoclave disinfection process.Based on the device analysis the final assessment is: there were no issues found related with the manufacturing process.
Event or Problem Description
Healthcare professional reported a right side capsular contracture, baker grade iii/iv.The device has been explanted.

• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 12583474
• Report Number: 9617229-2021-51362
• Device Sequence Number: 1401964
• Product Code: FTR
• UDI-Device Identifier: 10888628007024
• UDI-Public: 10888628007024
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/07/2022

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: 12/25/2023
• Device Model Number: SRM-195
• Device Catalogue Number: SRM-195
• Device Lot Number: 3304764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 01/13/2022; 04/14/2022; 05/12/2022
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 02/09/2022; 05/06/2022; 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2019
• 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: 22 YR
• Patient Sex: Female
• Patient Weight: 55 KG