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

Model Number 31202

Device Problems Material Integrity Problem (2978); Protective Measures Problem (3015)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation into this event.

Event Description

Hospital reported patient had bowel obstructions and also said mesh ring is not close enough to the edge and that makes it easy for bowel to stick to it.

Manufacturer Narrative

The review of the device history records indicates that the product was manufactured and inspected properly.There were no non-conformances related to this complaint.Although there are many issues with this patient there is not enough evidence to conclude that the mesh was the reason for the patient¿s condition.Clinical evaluation: 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.A hernia that cannot be reduced is described as incarcerated and generally requires surgical correction.Incarceration of an intestinal segment may be accompanied by nausea, vomiting, and significant pain, and is a true surgical emergency.C-qur v-patch 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.Small bowel obstruction is the most frequently encountered surgical disorder of the small intestine.The etiology includes foreign bodies, stones, meconium, tumors, inflammatory strictures, adhesions, hernias or carcinomas.Peritoneal adhesions are fibrous bands of tissues formed between organs that are normally separated and/or between organs and the internal body wall.Most intra-abdominal adhesions are ta result of peritoneal injury, either by a prior surgical procedure or due to intra-abdominal infection.Good surgical technique, careful handling of tissue, and minimal use and exposure of peritoneum to foreign bodies form the cornerstone of adhesion prevention.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

Three days after mesh was implant patient reported to emergency room with increasing abdominal pain, constipation, nausea, and increasing erythema around the incision site.

• Brand Name: C-QUR V-PATCH
• 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: 8130265
• MDR Text Key: 129246884
• Report Number: 3011175548-2018-01444
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862312027
• UDI-Public: 00650862312027
• Combination Product (y/n): N
• PMA/PMN Number: K090909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2021
• Device Model Number: 31202
• Device Catalogue Number: 31202
• Device Lot Number: 435593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2018
• 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 Weight: 112