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Model Number 31535
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 07/01/2016
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
Event Description
Received a report stating that mesh was implanted for hernia repair. Three years after mesh was implanted patient developed complications, infection and a rash. Mesh was removed.
Manufacturer Narrative
We are unable to fully investigate this report as no product number, lot number or sample was provided. There is no indication this event is due to a device failure. The reporter stated that the doctors report stated that the mesh could have gotten infection from a number of reasons. Clinical evaluation: an immunocompromised host is a patient who does not have the ability to respond normally due to an impaired or weakened immune system. Healing and infection poses a greater challenge for people living with immune deficiencies. This is partly because of medications prescribed such as steroids which decrease the inflammatory process. Steroids may actually increase risk of wound infection, and delayed healing of open wounds. Microorganisms can infect a surgical wound through various forms of contact, such as from the touch of a contaminated caregiver or surgical instrument, through microorganisms in the air, or through microorganisms that are already on or in your body and then spread into the wound. Other risks for surgical site infections (ssi) include a compromised patient, elderly and/or overweight patients, weakened immune systems and diabetes. Most ssis can be treated successfully with antibiotic medications. Sometimes additional surgery or procedures may be required. Abdominal adhesions are bands of fibrous tissue that can form between abdominal tissues and organs after abdominal surgery or inflammatory processes. Adhesions cause tissues and organs in the abdominal cavity to stick together. Surgery in the lower abdomen and pelvis carries an even greater chance of abdominal adhesions. Abdominal adhesions can become larger and tighter as time passes, sometimes causing problems years after surgery. Careful attention to proper fixation techniques and placement of the mesh product should be taken to help prevent excessive tension or disruption between the mesh material and connective tissue. Placing surgical mesh in contact with the intestines and/or improper surgical fixation can increase incidence of adhesions. The instructions for use state adequate mesh fixation is required to minimize post-operative complications and recurrence. The instructions for use state that complications may occur with the use of any surgical mesh include, but are not limited to pain, seroma, mechanical disruption of the tissue and /or mesh and adhesions when placed in direct contact with the viscera and other organs.
Manufacturer Narrative
A review of the manufacturing lot history and sterilization records was conducted. All in-process specifications and release criteria were met, including testing for suture retention (course and wale) and ball burst conducted on the mesh at incoming. Fourier-transform infrared spectroscopy testing, in-process visual inspection of the cured coated mesh/panels, coating density of the cured coated panels, and seal strength testing on both the pre-and-post-sterile atrium-applied packaging seals were also performed, with all requirements being met. Clinical evaluation: c-qur mesh is indicated for the repair of soft tissue deficiencies including hernia repair. New information was received from this diabetic patient that is not included in her medical record. She reports additional adverse effects associated with revision of her hernia repair including hemorrhage, fistula, intra-operative arrhythmia, and bowel injury resulting in a prolonged hospital stay. Bleeding is the biggest risk of any surgical procedure and may be the result of patient conditions, blood dyscrasias or surgical technique. Intra-operative blood loss may result in arrhythmia and hemodynamic instability. Stress may also contribute to arrhythmia. Stress is the body's reaction to harmful situations including health care problems and physical distress such as surgery. During a stress response heart rate and irregularity may increase, breathing may quicken, and blood pressure may rise. Fistulas are a known complication of hernia repairs. Risk factors include surgical technique used in fixation, presence of suture abscesses, and patient factors including obesity, diabetes mellitus, elder age and poor nutritional status. Fistulas are a late complication of repairs with mesh particularly if the mesh is in direct contact with the intestine. Gastrointestinal perforation is a hole that develops through the wall the digestive tract. It may be caused by a variety of factors including patient conditions, trauma or surgical technique. Adverse events may occur with the use of any surgical mesh include, but are not limited to, fistula formation, injuries to bowel or blood vessels, and mechanical disruption of the tissue. The instructions for use precaution that careful attention to surgical mesh handling, suture, staple, or tacker fixation is required in the presence of nerves and vessels in the surgical field. Diabetes is a contributing factor in poor healing due to poor circulation and immune deficiencies (as mentioned in the patient's medical record) and is associated with elevations in blood glucose. This report is based upon allegations that may form a potential lawsuit in which atrium medical would be named as a defendant. This report shall not be considered as an admission by atrium medical that the product described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the patient.
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Brand NameC-QUR MESH
Manufacturer (Section D)
hudson NH 03051
Manufacturer (Section G)
40 continental blvd.
merrimack NH 03054
Manufacturer Contact
theresa morin
10 bowman drive
hudson, NH 03051
MDR Report Key5988512
MDR Text Key55988673
Report Number1219977-2016-00205
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial,Followup,Followup
Report Date 09/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2015
Device Model Number31535
Device Catalogue Number31535
Device Lot Number10859150
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/29/2016 Patient Sequence Number: 1