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

Model Number NMR6133

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 10/23/2016

Event Type  Injury  

Event Description

It was reported the patient developed a staphylococcus infection after application of the absorb-able antibacterial envelope.The associated products were removed.No further 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
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TYRX, INC.; 1 deer park dr; suites g, e; monmouth jct NJ
• Manufacturer (Section G): TYRX, INC.; 1 deer park dr; suites g, e; monmouth jct NJ
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6164034
• MDR Text Key: 62109298
• Report Number: 3005619263-2016-00052
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2016
• Device Model Number: NMR6133
• Device Catalogue Number: NMR6133
• Device Lot Number: 16H15753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2016
• Date Device Manufactured: 08/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 97714 IPG, 977A260 LEAD, 977A260 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR