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

Model Number	TRF-770
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Lymphoma (3263); Anaplastic Large Cell Lymphoma (3264)
Date of Event	04/24/2019
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.Reason for reoperation: lymphoma alcl and late seroma of 50cc's or more.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported right-side "patient has been diagnosed with lymphoma alcl and late seroma of 50cc's or more." pathological markers have not been received.Device remains implanted.
Event or Problem Description
Pathological markers have been received.
Additional Manufacturer Narrative
Allergan is submitting this follow-up mdr in accordance with 21 cfr 803 following the recall of biocell® textured breast implants and tissue expanders in relation to the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (bia-alcl).Allergan did not submit this mdr within 30 days of allergan¿s decision to initiate the remedial action.Allergan has initiated an investigation to address late mdrs submitted related to 2011068-7/2/19-001-r.
Event or Problem Description
Allergan is submitting this follow-up mdr in accordance with 21 cfr 803 following the recall of biocell® textured breast implants and tissue expanders in relation to the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (bia-alcl).

• 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: 8714004
• Report Number: 9617229-2019-07395
• Device Sequence Number: 14119158
• Product Code: FTR
• UDI-Device Identifier: 10888628008427
• UDI-Public: 10888628008427
• Combination Product (Y/N): N
• Initial Reporter State: WI
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2020

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: 02/01/2021
• Device Model Number: TRF-770
• Device Catalogue Number: TRF-770
• Device Lot Number: 2875710
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 08/06/2019; 07/22/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 09/03/2019; 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2011068-7/2/19-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR