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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORP C-QUR V-PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31202
Device Problem Positioning Failure (1158)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/17/2015
Event Type  Injury  
Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
 
Event Description
Patient undergoing laparoscopic repair of incarcerated umbilical hernia. An 8cm circular atrium c-qur mesh was placed within the peritoneal cavity. The tails of the mesh were brought up through the middle of the fascial defect. The fascia was then closed using #1 pds suture in an interrupted fashion. Adequate closure of the fascial defect was obtained. The tails of the mesh were then secured to the fascia using 0 vicryl suture in the interrupted fashion. The perineal cavity was then reinsufflated with air. The laparoscope was inserted into the perineal cavity. The mesh was seen to be adjacent to the anterior abdominal wall. Attempts were made to secure the mesh to the anterior abdominal wall using a secure strap device. The tacker was unable to be adequately deployed into the mesh. Three attempts were made. Instead the mesh was sutured in place.
 
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Brand NameC-QUR V-PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section G)
ATRIUM MEDICAL CORP
40 continental blvd.
merrimack NH 03054
Manufacturer Contact
theresa morin
40 continental blvd
merrimack, NH 03054
6038645237
MDR Report Key5407028
MDR Text Key37384243
Report Number1219977-2016-00025
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080688
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2018
Device Model Number31202
Device Catalogue Number31202
Device Lot Number401267
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 Received02/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/18/2015
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: 02/03/2016 Patient Sequence Number: 1
Treatment
SECURESTRAP MODEL STRAP25 LOT JJK449
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