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

Model Number	SCM-275
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	02/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Allergan is implementing a plan to address the increased volumes.A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: visual analysis of the returned device identified white particles in shell and gel, and flat creases.The weight of the device was within specification.A microscopic analysis was performed which identified a puncture on the radius side assessed as surgical damage like consist in the use of some surgical tool.Based on the device analysis the final assessment is a puncture assessed as surgical damage like consist in the use of some surgical tool, and bubbles are related with the opening.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, rupture, "abnormal appearance", "palpations", and "bubble and cracked".
Event or Problem Description
Healthcare professional reported left side implant has some abnormal appearance, and palpations, it was stated that it " looks, and feels funny.Healthcare professional later reported "bubble and cracked' along with a capsular contracture, baker grade iii".Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b3.
Event or Problem Description
Healthcare professional reported left side implant has some abnormal appearance, and palpations, it was stated that it "looks, and feels funny.Healthcare professional later reported "bubble and cracked' along with a capsular contracture, baker grade iii".Device has been explanted.

• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 12197424
• Report Number: 9617229-2021-07592
• Device Sequence Number: 14702824
• Product Code: FTR
• UDI-Device Identifier: 10888628029859
• UDI-Public: 10888628029859
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2022

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: 12/28/2023
• Device Model Number: SCM-275
• Device Catalogue Number: SCM-275
• Device Lot Number: 3304778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2019
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 59 KG