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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
Device Problem Insufficient Information (3190)
Patient Problem Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
 
Event Description
Received a report of a patient complaining of discomfort. Patient had umbilical hernia repair in (b)(6) 2016 and is now reporting discomfort. Doctor reported a mass felt at site of implant.
 
Manufacturer Narrative
We are unable to fully investigate this report as no product number, lot number or sample was provided. There is no indication this event is due to a device failure. Clinical evaluation: umbilical hernia occurs when a section of the intestine pushes through a weak spot in the abdominal muscles, near the belly button. Conditions that lead to umbilical hernia are increased intra-abdominal pressure and weakened fascia at the level of the umbilicus. Also, obesity, ascites, multiple pregnancies, and large abdominal tumors all contribute to the development of umbilical hernias. Any surgery that causes a break in the skin can lead to a postoperative infection. Doctors call these infections surgical site infections (ssis) because they occur on the part of the body where the surgery took place. Microorganisms can infect a surgical wound through various forms of contact, such as from the touch of a contaminated caregiver or surgical instrument, through microorganisms in the air, or through microorganisms that are already on or in your body and then spread into the wound. Any ssi may cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling.
 
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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 Key5876118
MDR Text Key52105834
Report Number1219977-2016-00184
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/15/2016 Patient Sequence Number: 1
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