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

Model Number	ML-410285
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/15/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.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.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: implant "hard like rocks", "extremely painful at times." and is "larger", and infection.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 investigation results: with the information collected during the investigation, there is enough evidence to support that device serial number 20050490 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 30018201 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 (b)(6) 2018 through (b)(6)2020, were noted 2 outliers (sep-18 and apr-19).An additional analysis was performed to determine any pattern or any similarities relation between prs involved.It was found a primary packaging operator 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 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 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 right side "infection", "hard like rock", "extremely painful at times", is "larger" and "too big and interferes with arm movement." device remains implanted.

• 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: 10734527
• Report Number: 9617229-2020-10646
• Device Sequence Number: 1720656
• Product Code: FTR
• UDI-Device Identifier: 10888628003576
• UDI-Public: 10888628003576
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

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: 01/10/2020
• Device Model Number: ML-410285
• Device Catalogue Number: ML-410285
• Device Lot Number: 2705464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 10/26/2020
• 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
• Patient Age: 73 YR