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

Model Number	31507
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	12/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
Event or Problem Description
Following surgery for hernia repair, mesh was explanted due to recurrence.No infection was noted but a large inflammatory response was seen.Patient was tested for infection but none found.

• Brand Name: C-QUR MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• MDR Report Key: 6240276
• Report Number: 1219977-2017-00002
• Device Sequence Number: 19060958
• Product Code: FTL
• UDI-Device Identifier: 00650862315073
• UDI-Public: 00650862315073
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K050311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2016

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
• Operator of Device: Physician
• Device Model Number: 31507
• Device Catalogue Number: 31507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2016
• Initial Report FDA Received Date: 01/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR