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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR V-PATCH
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ATRIUM MEDICAL CORP. C-QUR V-PATCH Back to Search Results
Device Problems Entrapment of Device (1212); Material Protrusion/Extrusion (2979)
Patient Problems Abdominal Pain (1685); Discharge (2225)
Event Date 10/23/2014
Event Type  Injury  
Event Description
Pt had gall bladder removed (lap chole) and developed a hernia at the umbilicus.Mesh implanted 4 months later to treat the hernia.The pt complained of ongoing pain and discharge from the umbilicus and that the mesh was protruding from the skin.The pt trimmed the mesh himself and the symptoms continued.A diagnostic laparoscopy was performed and a small loop os bowel lightly adhered to the mesh was noted.The surgeon took down the adhesion and noticed pus between the abdominal layers so he removed the device via the umbilicus.The product was cultured for infection and the results were negative.
 
Manufacturer Narrative
We are in the process of performing the investigation and will submit the follow up report once the eval is completed.
 
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Brand Name
C-QUR V-PATCH
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer Contact
theresa morin
5 wentworth dr.
hudson, NH 03051
6038645237
MDR Report Key4249817
MDR Text Key4989795
Report Number1219977-2014-00373
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K080688
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 10/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/28/2014
Initial Date FDA Received11/07/2014
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 Sequence Number1
Treatment
KEFLEX
Patient Outcome(s) Required Intervention;
Patient Age48 YR
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