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

Catalog Number	FX-410315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Seroma (2069)
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 reported events of infection and late seroma 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 requested.No additional information is available at this time.The reasons for reoperation were implants started getting bigger, shooting pain, infection, and mastitis.These are known potential adverse events addressed in the product labeling.
Event or Problem Description
Patient reported "implants started getting bigger," "having shooting pain," "infection," "mastitis," and "fluid on implants." patient was treated with antibiotics for infection.Device has been explanted.This record is for the right side.
Event or Problem Description
Patient was treated with antibiotics three times for infection.Patient representative reported ¿had a nipple discharge which has resolved since second course of antibiotics." patient representative also reported patient was ¿constantly fatigued¿ and ¿having memory problems," these events are not related to the device.
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.  further investigation summary: with the information collected during the investigation, there is enough evidence to support that device serial number (b)(6) was manufactured under controlled conditions in accordance with allergan medical procedures.Seal strength results were acceptable.Environmental monitoring and bioburden results were found to be acceptable.The sterilization run (b)(4) 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) 2017 through (b)(6) 2019, was noted an outlier in (b)(6) 2017.An additional analysis was performed to determine any pattern or any similarities relation between pr¿s involved.It was found that some primary packaging operators were involved in more than one occasion, however the people were trained in the corresponding procedure.Also, calibrations, maintenance and validations of the equipments 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 was reviewed and no issues, deviations or ncs were found associated to either event.Given the fact that the cause of the infection cannot be specifically associated to costa rica 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: 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: 9098978
• Report Number: 9617229-2019-14608
• Device Sequence Number: 11463754
• Product Code: FTR
• UDI-Device Identifier: 10888628002968
• UDI-Public: 10888628002968
• Combination Product (Y/N): N
• Initial Reporter State: TN
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 10/30/2020
• Device Catalogue Number: FX-410315
• Device Lot Number: 2840427
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 01/16/2020
• 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