MAUDE Adverse Event Report: TYRX, INC. AIGIS-R LARGE; MESH, SURGICAL, POLYMERIC

Model Number	CMRM6133
Medical Device Problem Code	Device Expiration Issue (1216)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the antibacterial envelope was implanted one day past the use by date.The envelope remains in use and no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: AIGIS-R LARGE
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TYRX, INC.; 1 deer park dr.; suites g, e; monmouth jct NJ 08852
• MDR Report Key: 7256306
• Report Number: 3005619263-2018-00019
• Device Sequence Number: 13477720
• Product Code: FTL
• UDI-Device Identifier: 00643169468795
• UDI-Public: 00643169468795
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K130943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: 17K16190
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 10/28/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR