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

Model Number	FM-410310
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Capsular Contracture (1761); Deformity/ Disfigurement (2360)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Device analysis: analysis of the returned device identified: deformation device, creases flat, yellow particles and weight to the spec.Cloudy in the gel observed after autoclave cycle.Base on the device analysis the final assessment is: no issues found related with the manufacturing process.The events of "capsular contracture and symmastia" 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.Reason for reoperation: patient reported "they always hurt, i have sharp pains under my right breast and it feels hot.I have sharp pains under my armpits" and "unsatisfactory, symmastia worse on left than right and gross distortion of the inframammary fold on right side and change to smooth implants".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.
Event or Problem Description
Patient reported "they always hurt, i have sharp pains under my right breast and it feels hot.I have sharp pains under my armpits." additionally, healthcare professional reported "unsatisfactory, symmastia worse on left than right and gross distortion of the inframammary fold on right side and change to smooth implants." device has been explanted.This record is for the right 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
• MDR Report Key: 11663824
• Report Number: 9617229-2021-05181
• Device Sequence Number: 2935879
• Product Code: FTR
• UDI-Device Identifier: 10888628002845
• UDI-Public: 10888628002845
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2021

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: 04/26/2020
• Device Model Number: FM-410310
• Device Catalogue Number: FM-410310
• Device Lot Number: 2747386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 04/14/2021
• 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