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

Model Number CMRM6122

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the physician chose to implant the antibacterial envelope past the use by date.No patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: AIGIS-R MEDIUM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TYRX, INC.; 1 deer park dr; suites g, e; monmouth jct NJ 08852
• MDR Report Key: 7469394
• MDR Text Key: 107355568
• Report Number: 3005619263-2018-00051
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00643169935891
• UDI-Public: 00643169935891
• Combination Product (y/n): N
• PMA/PMN Number: K130943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

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
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: CMRM6122
• Device Catalogue Number: CMRM6122
• Device Lot Number: R095899
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 05/03/2018
• Supplement Dates FDA Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 89 YR