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

Model Number	MF-410525
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Impaired Healing (2378)
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.The events of "capsular contracture¿ and "delayed healing" 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: "capsular contracture,¿ baker grade not specified, ¿scabbing and delayed healing,¿ ¿increased risk of bia-alcl,¿ ¿anguish and anxiety,¿ ¿bilateral tightness¿ and ¿mental pain.¿.
Event or Problem Description
Patient representative reported patient experienced ¿capsular contracture,¿ baker grade not specified, ¿scabbing and delayed healing,¿ ¿increased risk of bia-alcl,¿ ¿anguish and anxiety,¿ ¿bilateral tightness¿ and ¿mental pain.¿ patient representative also reported patient experienced ¿suffering,¿ ¿disfigurement¿ and ¿suffered personal injuries and related damages;¿ these events are not related to the device.Device was explanted.This record is for the left side.
Event or Problem Description
Patient representative reported patient experienced ¿capsular contracture,¿ baker grade not specified, ¿scabbing and delayed healing,¿ ¿increased risk of bia-alcl,¿ ¿anguish and anxiety,¿ ¿bilateral tightness¿ and ¿mental pain.¿ patient representative also reported patient experienced ¿suffering,¿ ¿disfigurement¿ and ¿suffered personal injuries and related damages;¿ these events are not related to the device.Device was explanted.This record is for the left side.
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.

• 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: 10992446
• Report Number: 9617229-2020-21887
• Device Sequence Number: 3487197
• Product Code: FTR
• UDI-Device Identifier: 10888628003507
• UDI-Public: 10888628003507
• Combination Product (Y/N): N
• Initial Reporter State: CT
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2021

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: 07/04/2020
• Device Model Number: MF-410525
• Device Catalogue Number: FF-410475
• Device Lot Number: 2783962
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 04/18/2021
• 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