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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL C-QUR V-PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31202
Device Problem Malposition of Device (2616)
Patient Problem Obstruction/Occlusion (2422)
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
 
Event Description
Hospital reported patient had bowel obstruction 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
Ten days after mesh implant patient reported to emergency room with abdominal pain around incisional site that was radiating to his back along with occasional vomiting and inability to tolerate eating.
 
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Brand NameC-QUR V-PATCH
Type of DeviceMESH, 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 Key8130258
MDR Text Key129237607
Report Number3011175548-2018-01443
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K090909
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
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 Received12/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/03/2021
Device Model Number31202
Device Catalogue Number31202
Device Lot Number427780
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received12/13/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/21/2018
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: 12/04/2018 Patient Sequence Number: 1
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