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

Catalog Number	TSX-615
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Failure of Implant (1924); Swollen Lymph Nodes (2093)
Date of Event	06/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for reoperation is rupture.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 rupture, ipsilateral silicone lymphadenopathy and pain.The device remains implanted.
Event or Problem Description
The device was explanted.

• 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: 8786159
• Report Number: 9617229-2019-06229
• Device Sequence Number: 13934582
• Product Code: FTR
• UDI-Device Identifier: 10888628034426
• UDI-Public: 10888628034426
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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 Catalogue Number: TSX-615
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/20/2019
• 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: 47 YR