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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31531
Device Problem Material Separation (1562)
Patient Problems Abscess (1690); Adhesion(s) (1695); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Discharge (2225); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Blood Loss (2597); Fibrosis (3167); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Investigation: based on the review of the device history and sterilization records and product complaint details atrium can find no fault with the product. This lot of mesh passed all quality and performance requirements. This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant. This report shall not be considered as an admission by atrium medical that the product described in the lawsuit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the plaintiff.
 
Event Description
This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical's mesh product. Plaintiff allegedly experienced ventral hernia, incisional hernia, recurrence, incarceration, component separation, small bowel obstruction, ischemic bowel, inflammation, infection, abscess, purulent drainage, fibrosis, adhesions, unincorporated mesh, hemodynamic instability, hypotension, blood loss and acute kidney injury. Since this is a legal matter, the case has been turned over to legal counsel and further information obtained through investigation or discovery may fall under attorney/client privilege. However, atrium will supplement this report as appropriate if additional information comes to its attention.
 
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Brand NameC-QUR MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key8489660
MDR Text Key141163375
Report Number3011175548-2019-00364
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 other
Type of Report Initial
Report Date 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2014
Device Model Number31531
Device Catalogue Number31531
Device Lot Number10741220
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received04/02/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/19/2011
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: 04/05/2019 Patient Sequence Number: 1
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