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

Model Number	TSF-650
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Lymphoma (3263)
Date of Event	05/04/2020
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 event of "seroma" is a physiological complication 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 fluid, 50 cc's and patient concern with the product.
Event or Problem Description
Healthcare professional reported a right side "seroma fluid, 50 cc's or greater" and an "exchange of textured breast implants due to the patient¿s concern with the product." device remains implanted.
Additional Manufacturer Narrative
Additional data: b.5, b.6, b.7, h.6.Date of alcl diagnosis: unknown date.
Event or Problem Description
Healthcare professional additionally reported "positive alcl testing." pathological markers confirming alcl have not been received.

• 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: 10116791
• Report Number: 9617229-2020-08174
• Device Sequence Number: 2142636
• Product Code: FTR
• UDI-Device Identifier: 10888628034228
• UDI-Public: 10888628034228
• Combination Product (Y/N): N
• Initial Reporter State: NV
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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: 12/26/2021
• Device Model Number: TSF-650
• Device Catalogue Number: TSF-650
• Device Lot Number: 3013197
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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: 33 YR