MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR V-PATCH MESH; MESH, SURGICAL, POLYMERIC

Model Number 31200

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 04/01/2015

Event Type  Injury  

Event Description

Open umbilical hernia without issue.In (b)(6) patient began complaining of "severe pain" and a purple/blue discoloration on and around her incision/scar.

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.

Manufacturer Narrative

The lot history and sterilization records were reviewed.All records were found to be complete and showed that the product was manufactured to specifications.The following testing was required, and performed for this product: analysis of fish oil, fourier-transform infrared spectrophotometry (ftir) testing for coated mesh panels, suture retention and ball burst testing of bare mesh panels, and stitch strength testing.The analysis of fish oil showed that all requirements for chemical composition met acceptance criteria.The manufacturing records, inspection records, and sterilization records showed no non conformances or deviations.Based on the lot history review, there are no indications that the product was responsible for the incident reported.Clinical opinion: refractory chronic pain is characterized by pain that persists despite treatment and for longer than expected.Causes are varied and pain can occur anywhere in the body.Complications may occur due to a technical error, inadequate fixation and/or inadequate overlap which will cause separation of the mesh from the abdominal wall thereby increasing the possibility of infection, perforation, seroma, adhesions and pain.The instructions for use state complications that may occur with the use of any surgical mesh include, but are not limited to, inflammation, infection or mechanical disruption of the tissue and/or mesh material and possible adhesions when placed in direct contact with the viscera (intestines).

• Brand Name: C-QUR V-PATCH MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH
• Manufacturer Contact: theresa morin ; 5 wentworth drive; hudson, NH 03051 ; 6038645237
• MDR Report Key: 4849867
• MDR Text Key: 5933831
• Report Number: 1219977-2015-00172
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 31200
• Device Catalogue Number: 31200
• Device Lot Number: 210643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 39 YR