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

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/13/2013

Event Type  Injury  

Event Description

Medwatch was received on (b)(6) 2014 and the following info was alleged.The mesh used for hernia repair became dislodged from the original surgical repair site.It entangled with the muscle tissue in the abdomen and had to be surgically removed because the pt experienced pain and had an infection.The pt was hospitalized for 10 days and received vancomycin (7 days) and clindamycin (antibiotics) as well as dilaudid for pain every 4 hours.

Manufacturer Narrative

The device was not returned for eval.The product part number or lot number was not provided, therefore, a device history record review could not be performed.An independent clinician was consulted and the clinician's opinion, based on available info, is that the incidence of the mesh dislodgement from its original location is due to an inadequate surgical repair.There was either inadequate tissue overlapping, inadequate fixation of the mesh, or both.Once dislodged, the mesh may migrate along the direction of native intra-abdominal pressure (in to out).In addition, contracture of the non-fixated mesh, would cause it to ball up.Pain would be common, but infection is more unusual.See scanned page.

• Brand Name: C-QUR MESH
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: lori gosselin, sr specialist ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3716223
• MDR Text Key: 4249011
• Report Number: 1219977-2014-00016
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention