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

Model Number	MM-410360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
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 event of infection(early onset) 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: "capsule excision due to an infection.".
Event or Problem Description
Patient representative reported removal due to ¿capsule excision due to an infection,¿ patient experienced ¿debilitating physical pain and mental suffering,¿ ¿mental stress, anxiety, worry, humiliation, fear, and other personal ¿ hardship due to the continuous fear of biaalcl,¿ ¿suffered, or will suffer, painful removal procedures to mitigate the risk of developing bia-alcl, as well as any treatment, therapy, recovery, ¿ associated with the removal of the biocell textured breast implants, the potential for the development of bia-alcl, and any condition or symptoms associated with bia-alcl or the prevention of that issue¿ and ¿suffered emotional distress, anxiety¿ loss of quality of life.¿ patient representative also reported patient experienced "depression" and "disability;" these events are not related to the device.Device was explanted.This record is for the left 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; CS
• MDR Report Key: 10568594
• Report Number: 9617229-2020-15557
• Device Sequence Number: 16820605
• Product Code: FTR
• UDI-Device Identifier: 10888628003644
• UDI-Public: 10888628003644
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2020

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: 11/08/2021
• Device Model Number: MM-410360
• Device Catalogue Number: MM-410360
• Device Lot Number: 2997264
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/22/2020
• 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