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

Model Number	FX-410690
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/20/2019
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.Device evaluation: analysis of the returned device identified overweight, deformation, crease fold.Cloudy and voids in the gel observed after autoclave cycle.After weighting the device, it is observed that it is overweight, however, a review of the weight reports generated during the manufacturing process is performed and all units were within specification.Therefore, the overweight observed during the additional analysis is not considered a workmanship (see the weight report attached).Based on the device analysis the final assessment is: no issues found related with the manufacturing process.The event of pain 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: pain.
Event or Problem Description
Healthcare professional reported left side reason for removal as 'pain'.Device has been explanted.

• 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: 10001427
• Report Number: 9617229-2020-07590
• Device Sequence Number: 11589020
• Product Code: FTR
• UDI-Device Identifier: 10888628003033
• UDI-Public: 10888628003033
• Combination Product (Y/N): N
• Initial Reporter State: IA
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 12/18/2022
• Device Model Number: FX-410690
• Device Catalogue Number: FX-410690
• Device Lot Number: 3152981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 04/27/2020
• 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: 41 YR