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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Pain (1994); Seroma (2069)

Event Type  Injury  

Event Description

Received report of the following observations: more post-operative complications in the last twelve months, an increase in seroma formation around the mesh and in-between the mesh and abdominal wall (no specifics on occurrences), increase in post-operative infection; he said he had never had an infection using c-qur and now has seen 4-5 in past 12 months, he is noticing an increase in post-operative pain. The doctor feels that the material is not acting the same and suggested that may be our process has changed since we have been under maquet.

Manufacturer Narrative

Investigation: a thorough investigation into this event was not possible as no product lot number, or sample is available for investigation. A review of our complaints database reveals that there have not been any reports received that were attributed to a device malfunction. This report was for more than one event. We have requested more information. As there are no specifics for any of the events one report is being submitted. If any additional information is received, that would impact this report, than a follow up report will be submitted.

• Brand Name: C-QUR MESH
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: theresa morin, manager ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3485863
• MDR Text Key: 4081402
• Report Number: 1219977-2013-00160
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/21/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2013
• 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 Treatment Data

Date Received: 11/13/2013 Patient Sequence Number: 1