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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR MESH
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ATRIUM MEDICAL CORP. C-QUR MESH Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problem No Code Available (3191)
Event Date 01/02/2012
Event Type  Other  
Event Description
Pt had a ventral hernia repair in (b)(6) 2011 at (b)(6). Pt. Stated, "there were no problems with this procedure or mesh". On (b)(6) 2011, while on holiday in (b)(6), pt. Experienced continuous vomiting. He was admitted to (b)(6) on (b)(6) 2011, with a diagnoses of a partially blocked colon and reactivated hernia. Pt. Had interventional surgery on (b)(6) 2012. Mesh was totally detached and "had wrapped around a series of colons and 'strangled' them. ".
 
Manufacturer Narrative
The device product code and lot number were not provided in the letter, therefore no lot history review was conducted. No conclusion regarding the reported event was possible with the limited information that was provided.
 
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Brand NameC-QUR MESH
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
5 wentworth dr.
hudson NH 03051
Manufacturer Contact
lori gosselin, sr. specialist
5 wentworth dr.
hudson, NH 03051
6038801433
MDR Report Key2519804
MDR Text Key2598283
Report Number1219977-2012-00007
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100076
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Unknown
Reporter Occupation
Type of Report Initial
Report Date 03/28/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2012
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/15/2012
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: 03/28/2012 Patient Sequence Number: 1
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