MAUDE Adverse Event Report: INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	TRM-600
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swollen Lymph Nodes (2093)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted beyond 30 calendar days from allergan¿s receipt due to a system error preventing allergan from submitting reports via emdr.The system error has been resolved at this time and an investigation has been initiated into this occurrence.A review of the device history record has been completed.No deviations or non-conformances noted.The event of swollen lymph nodes 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.The reason for reoperation is "enlarged lymph nodes in neck and armpit" and "elevated immune levels.".
Event or Problem Description
Patient reported a "enlarged lymph nodes in neck and armpit" on an unspecified side, and "elevated immune levels" device remains implanted.This record is for the right sides.
Event or Problem Description
Patient reported a "enlarged lymph nodes in neck and armpit" on an unspecified side, and "elevated immune levels".Device remains implanted.This record is for the right sides.
Event or Problem Description
Explanting physician reported, ¿rupture/ texture¿.The device was explanted.

• Brand Name: INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• MDR Report Key: 9952986
• Report Number: 9617229-2020-05558
• Device Sequence Number: 10926351
• Product Code: FTR
• UDI-Device Identifier: 10888628008182
• UDI-Public: 10888628008182
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2021

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: 06/06/2020
• Device Model Number: TRM-600
• Device Catalogue Number: TRM-600
• Device Lot Number: 2766715
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 04/30/2020; 10/05/2021
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 05/29/2020; 11/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2015
• 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