MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR TACSHIELD; MESH, SURGICAL, POLYMERIC

Model Number 31628

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

Patient Problems Fever (1858); Seroma (2069); Chills (2191)

Event Date 05/13/2014

Event Type  Injury  

Event Description

Pt has recurrent incisional hernia repaired with mesh.Two and a half yrs later, pt has a mass on the abdominal wall and recent episode of fever and chills.

Manufacturer Narrative

We are unable to fully investigation this report as no product code, lot number, or sample was provided.An outside clinician was consulted on this event.His opinion was that seroma formation is part of the normal healing process, usually resorbing on its own over time.There will be a plane between the mesh and the fascia during placement of the prosthetic.Fluid builds up in this space.It should resorb on its own, or can be drained with a radiologic procedure.There are instances when they can be more persistent but this is unusual.The clinician also believes the pts fever and chills are more likely due to cholangitis (bile duct infection).

• Brand Name: C-QUR TACSHIELD
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: theresa morin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645237
• MDR Report Key: 3883758
• MDR Text Key: 14873808
• Report Number: 1219977-2014-00175
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 31628
• Device Catalogue Number: 31628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 69 YR