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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Seroma (2069)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported a left side capsular contracture, baker grade ii, ¿small amount of fluid," and "initially the gram stain was negative and later grew out mrsa." device has been explanted.
Additional Manufacturer Narrative
(b)(4).A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: analysis of the returned device identified the weight the device within specification, white particles in the shell, deformation and crease fold.Cloudy in the gel observed after autoclave cycle.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.The events of seroma - late and infection (unknown onset) 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/will be requested.No additional information is available at this time.Reason for reoperation: ¿small amount of fluid"; "initially the gram stain was negative and later grew out mrsa" further investigation results: with the information collected during the investigation, there is enough evidence to support that device serial number 23591955 was manufactured under controlled conditions in accordance with allergan procedures.Seal strength results were acceptable.Environmental monitoring results were found to be acceptable and they confirmed that there was not an adverse impact on environmental conditions, device quality or performance.The sterilization run 30032269 is not related to any additional complaint infection record reported as of today.During the trend review of all infection complaints for the period of apr-2020 through mar-2022, no adverse trend was noted.Given the fact that the cause of the infection cannot be specifically associated to the manufacturing process, and there is not an adverse trend for this type of event no corrective action is deemed necessary at this time.

• 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: 15940875
• Report Number: 9617229-2022-06031
• Device Sequence Number: 6200743
• Product Code: FTR
• UDI-Device Identifier: 10888628030336
• UDI-Public: 10888628030336
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 12/08/2022

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: 09/11/2023
• Device Model Number: SCX-495
• Device Catalogue Number: SCX-495
• Device Lot Number: 3264567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2018
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 71 KG