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-410615
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Granuloma (1876); Seroma (2069)
Date of Event	01/01/2022
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 reported events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.As the initial reporter is a legal representative, follow-up is not possible, therefore additional event, product, and/or patient details are not attainable.The reason for reoperation is: ¿delayed seroma¿, ¿granulomatous changes¿, and "fear of alcl, to reduce risk of alcl".
Event or Problem Description
Patient representative reported for left side, the patient suffered an "accumulation of fluid¿, ¿drainage of fluid¿, ¿delayed seroma¿, ¿granulomatous changes¿, ¿removal of implants due to fear of alcl, to reduce risk of alcl, and due to symptoms consistent with alcl and fear of alcl¿, ¿mental anguish and fear of alcl, increased risk of alcl¿, ¿anxiety¿, and ¿imaging and pathological evaluation to rule out bia-alcl¿, ¿chronic inflammation¿, ¿swelling¿, ¿pain¿, ¿redness¿, "erythema", ¿tightness¿, ¿depression¿.In addition, the following non-device related events were also reported as follows: ¿significant scarring and disfigurement¿, ¿other physical and emotional manifestations that are severe and ongoing¿ and ¿suffered loss of wages and wage-earner capacity¿.The 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 14759800
• Report Number: 9617229-2022-10121
• Device Sequence Number: 19165976
• Product Code: FTR
• UDI-Device Identifier: 10888628003026
• UDI-Public: 10888628003026
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2022

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: 05/20/2022
• Device Model Number: FX-410615
• Device Catalogue Number: FX-410615
• Device Lot Number: 3068588
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female