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

Model Number	MX-410520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Lymphoma (3263)
Date of Event	01/18/2021
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 event of lymphoma-alcl is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.No contact information was provided for the initial reporter, therefore additional event, product, and/or patient details are not attainable.Reason for reoperation: "patient has been diagnosed with bia-alcl".
Event or Problem Description
Patient representative reported left side ¿chronic pain,¿ ¿itching,¿ ¿swelling,¿ ¿heat sensation,¿ ¿anxiety¿ ¿explant surgery due to fear of developing alcl, to reduce the risk of alcl¿ ¿mental anguish and fear of developing alcl,¿ ¿patient has been diagnosed with bia-alcl.¿ patient representative additionally reported ¿chronic insomnia, significant weight gain,¿ ¿chronic gastrointestinal reflux¿ ¿disfigurement,¿ and ¿chronic headaches¿ not related to the device.Pathological markers confirming alcl have not been received.The device has been explanted and replaced.

• 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: 12475114
• Report Number: 9617229-2021-51807
• Device Sequence Number: 14438139
• Product Code: FTR
• UDI-Device Identifier: 10888628003767
• UDI-Public: 10888628003767
• 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: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

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: 12/05/2021
• Device Model Number: MX-410520
• Device Catalogue Number: MX-410520
• Device Lot Number: 3003412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/15/2021
• 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
• Patient Age: 58 YR