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

Model Number 31200

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Rash (2033)

Event Date 11/26/2014

Event Type  Injury  

Event Description

Following the placement of the mesh, the pt developed a rash on their abdomen and abdominal pain.Pt was treated with antibiotics and greatly improved.

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the eval is completed.

• Brand Name: C-QUR V-PATCH
• 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: 4346168
• MDR Text Key: 15321754
• Report Number: 1219977-2014-00397
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 31200
• Device Catalogue Number: 31200
• Device Lot Number: 202268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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: 49 YR
• Patient Weight: 63