MAUDE Adverse Event Report: ATRIUM MEDICAL; MESH, SURGICAL, POLYMERIC

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation a follow up report will be submitted.

Event Description

Received report that surgeon may have inadvertently implanted uncoated mesh into the abdomen.

Manufacturer Narrative

We are unable to fully investigate this report as no product code, lot number or sample was provided.Clinical investigation: ventral hernias are hernias of the anterior abdominal wall and represent defects in the parietal abdominal wall fascia and muscle through which abdominal contents can protrude.C-qur mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.An incisional hernia develops from failed healing of an abdominal wall incision.They may be asymptomatic or cause a considerable degree of discomfort and will generally enlarge over time.C-qur¿ mesh has a coating derived from biological oil composed of fatty acids, lipids and glycerides (bao bio-absorbable oil coating).It has a coating that is absorbable by the body and if in the event it does flake or come off during a procedure it would cause no harm to the patient, the mesh would then become the equivalent of bare mesh.Laparoscopic incisional hernia repair with intraperitoneal mesh is associated with a certain degree of adhesion formation to the mesh.Coated mesh is intended to encourage adhesion reduction.The instructions for use (ifu) states complications that may occur with the use of any surgical mesh include, but are not limited to, pain, inflammation, infection, allergic reaction, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material and possibly adhesions when placed in direct contact with the viscera and other organs.The patient should be advised to contact the physician should an adverse reaction occur.

Event Description

N/a.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 8037855
• MDR Text Key: 126115002
• Report Number: 3011175548-2018-01261
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: No
• 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: 53 YR