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

Model Number	SCF-335
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/24/2020
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 "infection¿ 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: infection (unknown onset).
Event or Problem Description
Healthcare professional reported left side "infection." device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Further investigation: with the information collected during the investigation, there was enough evidence to support that the device was manufactured under controlled conditions in accordance with allergan procedures.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 was not related to any additional complaint infection record reported at time of investigation.During the trend review of all infection complaints for gel breast implants for the period of (b)(6) 2018 through (b)(6) 2020, two outliers were noted in (b)(6) 2018 and (b)(6) 2019.An additional analysis was performed to determine any pattern or any similarities relation between records involved.A primary packaging operator was involved in more than one occasion in this process, however the person was trained in the corresponding procedure.Also, it was found a sealer and a sterilizer involved in more than one occasion on those processes, however, calibrations, maintenance and the validation processes of these equipment involved, were reviewed and it was determined that they were performed on time and met specifications.In addition, all the records involved in the current month were reviewed and no issues were found associated to either event.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 the time of investigation.
Event or Problem Description
Healthcare professional reported left side "infection." 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; CS
• MDR Report Key: 10384558
• Report Number: 9617229-2020-13096
• Device Sequence Number: 19694794
• Product Code: FTR
• UDI-Device Identifier: 10888628030084
• UDI-Public: 10888628030084
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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: 05/05/2022
• Device Model Number: SCF-335
• Device Catalogue Number: SCF-335
• Device Lot Number: 3063373
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention