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-410775
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Seroma (2069)
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 seroma and infection are a physiological complications 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: seroma-late and infection (unknown onset).Device evaluation: analysis of the returned device identified overweight, crease fold, deformation and wear abrasion.Cloudy and voids in the gel observed after autoclave cycle.After weighting the device, it is observed that it is overweight, however, a review of the weight reports generated during the manufacturing process is performed and all units were within specification.Therefore, the overweight observed during the additional analysis is not considered a workmanship (see the weight report attached).Based on the device analysis the final assessment is: no issues found related with the manufacturing process.
Event or Problem Description
Patient reported bilateral "non-stop itching" and "deep pains around the sides of the breast." healthcare professional reported left side implant" breast pain, joint pain, and night sweats." patient representative reported "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, evaluation for alcl, increased risk of alcl, implant removal, capsulectomy, significant scarring, disfigurement, tissue damage, pain, swelling, rashes, itching, seroma, asymmetry, chronic inflammation, depression, anxiety, panic disorder, posttraumatic stress, chronic insomnia, significant weight loss and gain, irritable bowel, chronic headache, chronic gi upset/reflux; post-operative complications including inflammation, fluid accumulation, infection; aggravation of underlying conditions; and other physical and emotional manifestations that are severe and ongoing.At this time it is unclear if plaintiff was enrolled in any of defendant¿s clinical trials or studies.Patient has not been diagnosed with bia-alcl." this record is for the left side.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: 14212330
• Report Number: 9617229-2021-55977
• Device Sequence Number: 1841031
• Product Code: FTR
• UDI-Device Identifier: 10888628003040
• UDI-Public: 10888628003040
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2022

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: 09/30/2020
• Device Model Number: FX-410775
• Device Catalogue Number: FX-410775
• Device Lot Number: 2823337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2015
• 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 Sex: Female