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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

Hospital reported three events of allergy after using in open case.He did not give any further details.

Manufacturer Narrative

We are unable to perform a full investigation as no sample, product code or lot number was available.Review of complaints does not show any similar reports related to a device failure.If any further details are provided a follow up report will be submitted.The other two reports are: 1219977-2014-00079.1219977-2014-00080.

• Brand Name: C-QUR MESH
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: theresa morin, capa mgr ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3687976
• MDR Text Key: 4288510
• Report Number: 1219977-2014-00081
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050311
• 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: 11/07/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2012
• 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