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

Model Number CMRM6133

Device Problem Device Expiration Issue (1216)

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

Event Date 07/01/2014

Event Type  malfunction  

Event Description

It was reported that during the implant procedure the sales representative noticed the product was beyond its "use-before-date." the physician requested use of the product.The product was implanted and remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

• Brand Name: AIGIS-R LARGE
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TYRX, INC.; 1 deer park dr.; suites g, e; monmouth jct NJ 08852
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 4161095
• MDR Text Key: 4868182
• Report Number: 3005619263-2014-00008
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2014

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: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: 14E05451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2014
• Initial Date FDA Received: 10/10/2014
• Date Device Manufactured: 05/27/2014
• 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
• Patient Age: 00074 YR