MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	MX-410620
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
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
Patient reported "had to have implant removed due to an infection that was so severe they were near death." device has been explanted.This record if for the left side.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Further investigation results: with the information collected during the investigation, there is enough evidence to support that device 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 number is not related to any additional complaint infection record reported as of today.During the trend review of all infection complaints for gel breast implants for the period of apr/2018 through mar/2020, it was noted an outlier in (b)(6) 2018.An additional analysis was performed to determine any pattern or any similarities relation between records involved.It was found that one primary packaging operator was involved in more than one occasion; however, the person was trained in the corresponding procedure.Also, calibrations, maintenance and validations of the equipment involved in more than one occasion were reviewed and it was determined that they were performed on time and met specifications.In addition, all the records involved in this 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 this time.
Event or Problem Description
Patient reported "had to have implant removed due to an infection that was so severe they were near death." device has been explanted.This record is for the left side.

• Brand Name: STYLE 410 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: 9957495
• Report Number: 9617229-2020-07217
• Device Sequence Number: 2817632
• Product Code: FTR
• UDI-Device Identifier: 10888628003781
• UDI-Public: 10888628003781
• Combination Product (Y/N): N
• Initial Reporter State: WY
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

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: 08/07/2020
• Device Model Number: MX-410620
• Device Catalogue Number: MX-410620
• Device Lot Number: 2802316
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 06/04/2020
• 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