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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Swelling/ Edema (4577)
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.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 lymphedema.
Event or Problem Description
Patient representative reported, ""the plaintiff underwent painful removal procedures as well as treatment, therapy, recovery, and expense associated with the removal of the biocell textured breast implants due to fear of alcl, to reduce risk of alcl, and due to symptoms consistent with alcl and fear of alcl including: mental anguish, increased risk of alcl, evaluation for alcl, explant, reconstruction, seromas, physical pain, scarring and ]disfigurement.Plaintiff experienced breast pain, hardening of breasts, breast swelling, asymmetry, heat sensations, rashes or itching, poor circulation in right leg, physical weakness and limited mobility, and aggravation of lymphedema.Additionally, plaintiff suffered aggravation of underlying conditions including emotional distress, panic disorder, and anxiety, as well as loss of quality of life, depression, and ptsd; and other physical and emotional manifestations that are severe and ongoing." patient does not have and was not diagnosed with alcl.This record is for the right side.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: 14855635
• Report Number: 9617229-2022-11119
• Device Sequence Number: 5562295
• Product Code: FTR
• UDI-Device Identifier: 10888628003507
• UDI-Public: 10888628003507
• 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: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2022

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: 11/29/2019
• Device Model Number: MF-410525
• Device Catalogue Number: MF-410525
• Device Lot Number: 2688433
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2014
• 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