MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR MESH

Model Number 31528

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Adhesion(s) (1695); Pain (1994)

Event Type  Injury  

Event Description

This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical mesh product.Plaintiff alleges that she had a mesh implanted for hernia repair and experienced pain and discomfort.Allegedly, the physician removed the mesh which adhered to both the omentum and the small bowel.Since this is a legal matter, the case has been turned over to legal counsel and further information obtained through investigation or discovery may fall under the attorney/client and/or work product privilege.However atrium will supplement this report as appropriate if additional information comes to its attention.

Manufacturer Narrative

Upon completion of investigation into this event, a follow up report will be submitted.

Manufacturer Narrative

Additional information: a.2, b.5, b.7.Corrected informaton: d.4.

Event Description

Plaintiff allegedly also experienced recurrence and component separation.

• Brand Name: C-QUR MESH
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• MDR Report Key: 4275854
• MDR Text Key: 16995050
• Report Number: 1219977-2014-00377
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Model Number: 31528
• Device Catalogue Number: 31528
• Device Lot Number: 10611131
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 11/20/2014
• Supplement Dates Manufacturer Received: 11/04/2019; 04/06/2020
• Supplement Dates FDA Received: 11/06/2019; 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR