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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR V-PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31202
Device Problem Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/19/2016
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
 
Event Description
Hospital reported they received a unit with a twisted ring and would not lay flat. Procedure was open umbilical hernia repair.
 
Manufacturer Narrative
A review of lot history and sterilization records was performed. The finished good and subassembly lots passed all in-process inspections and testing including but not limited to fourier transform infrared spectroscopy and seal strength on pre and post sterile pouches. All raw materials met all incoming testing and inspections. Review shows that this lot met all sterilization and manufacturing acceptance criteria for lot release. The inspection of the mesh revealed several areas of coating delamination although the stitching around the perimeter was intact. The ring in the center of the device was intact, the correct size and laid flat. Consequently, the c-qur v-patch mesh sample was still conforming and would have been acceptable for use. When the product was returned the ring was lying flat. Due to limited information provided, the cause of the complaint cannot be determined. Clinical evaluation: when a procedure is planned and preparations are made, the required product is introduced to the procedure table prior to the start of the procedure. Product, expiration date, size and sterility/package integrity are inspected and confirmed with two clinicians at that time. If there was a defect in the product it would be noticed at that time and a replacement would be located. This would represent a delay for the patient who is confined to an operating table and under sedation or anesthesia, increasing the risk of immobility and prolonged sedation time. The complaint states that the ring of the mesh was twisted and would not lay flat. A product is used or discarded at the discretion of the physician. A defective product is not expected to be used in a procedure. The instructions for use warn, please inspect packaging to ensure it is intact and not damaged prior to use.
 
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Brand NameC-QUR V-PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH
Manufacturer Contact
theresa morin
40 continental blvd
merrimack, NH 03054
6038645237
MDR Report Key5636787
MDR Text Key44589126
Report Number1219977-2016-00092
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090909
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2017
Device Model Number31202
Device Catalogue Number31202
Device Lot Number203053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2014
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: 05/06/2016 Patient Sequence Number: 1
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