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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL C-QUR MESH; MESH, SURGICAL, POLYMERIC
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ATRIUM MEDICAL C-QUR MESH; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Seroma (2069); Hernia (2240); Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative
A complete investigation was not able to be performed as no product code, lot number or sample was provided per the study, non-operative management could be considered first-line therapy in these cases.[(b)(4)].
 
Event Description
Received an article titled: a novel nonoperative approach to abdominal compartment syndrome after abdominal wall reconstruction.The article describes the successful treatment of a severe acute case by intubation, nasogastric decompression, and paralysis for abdominal compartment syndrome following hernia repair with a c-qur mesh.Per the article, adverse events included seroma, non-healing wound, pain and recurrence.
 
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Brand Name
C-QUR MESH
Type of Device
MESH, 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 Key7495107
MDR Text Key107620754
Report Number3011175548-2018-00447
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation Physician
Type of Report Initial
Report Date 05/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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