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

Model Number	TRM-360
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Swollen Lymph Nodes (2093)
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 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: lymphadenopathy and capsular contracture, baker grade iv.These are a known potential adverse events addressed in the product labeling.
Event or Problem Description
Patient reported right side "lump, shooting and aching pain, swollen lymph nodes in head and arm pit, flu like symptoms," and "capsular contracture," baker grade iv.¿ patient additionally reported "fatigue;" this event is not related to the device.Device remains implanted.
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.Additional, changed, and/or corrected data.
Event or Problem Description
Patient representative reported "patient would not have had the recalled biocell product implanted had she known prior to her surgery that the biocell textured implants increased her risk of contracting bia-alcl, in addition to the costs associated with surgical removal of the implants and medical monitoring." the device has been explanted and replaced.

• Brand Name: INSPIRA TEXTURED 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: 9255316
• Report Number: 9617229-2019-17189
• Device Sequence Number: 2486635
• Product Code: FTR
• UDI-Device Identifier: 10888628008113
• UDI-Public: 10888628008113
• Combination Product (Y/N): N
• Initial Reporter State: LA
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: 02/21/2021
• Device Model Number: TRM-360
• Device Catalogue Number: TRM-360
• Device Lot Number: 2887963
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 07/11/2020
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 09/10/2021
• 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