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

Model Number 31200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/02/2014

Event Type  Injury  

Event Description

Patient developed a seroma after having umbilical hernia surgery.Seroma was cultured and drained.Physician does not suspect product involvement.(b)(6) on post operative day 25.Placed on monocycline orally at home and iv antibiotic at hosp.Infection resolved once seen on (b)(6) 2014; seen in the er and kept overnight.

Manufacturer Narrative

Investigation: review of manufacturing records found no issues during mfr or sterilization that would impact this event.Clinical evaluation: it was reported that a patient had an umbilical hernia repair with an atrium mesh.Early the next day, the patient complaint of redness, swelling and pain at the site.Patient had a history of (b)(6).The culture came back heavy growth staph aureus.Patient was treated with appropriate antibiotics.The product is contraindicated where tissue may be contaminated or infected.Any surgery that causes a break in the skin can lead to a surgical site infection (ssi).Infection could lead to the need for further intervention.Microorganisms in the air, or through microorganisms that are already on or in your body and then spread into the wound.Any ssi may cause redness delayed healing, fever, pain, tenderness, warmth, or swelling.

• Brand Name: C-QUR V-PATCH MESH
• 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: 4478152
• MDR Text Key: 5321454
• Report Number: 1219977-2015-00032
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K08068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: 31200
• Device Catalogue Number: 31200
• Device Lot Number: 10898196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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: 28 YR
• Patient Weight: 122