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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR MESH
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ATRIUM MEDICAL CORPORATION C-QUR MESH Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Seroma (2069)
Event Type  Injury  
Event Description
Received report of seven large seromas, some accompanied by skin reactions, with c-qur.Doctor has been using product for four years.Doctor does not feel seroma rate was unusual as he has done over 100 cases with c-qur.
 
Manufacturer Narrative
We are unable to perform a full investigation as no sample, product code or lot number was available.Review of complaints does not show any similar reports related to a device failure.If any further details are provided a follow up report will be submitted.The other six reports are: 1219977-2014-00085, 00086, 00088, 00089, 00090 and 00091.
 
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Brand Name
C-QUR MESH
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH
Manufacturer Contact
theresa morin, mgr
5 wentworth dr.
hudson, NH 03051
6038801433
MDR Report Key3687956
MDR Text Key4288020
Report Number1219977-2014-00087
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/01/2012
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/01/2012
Initial Date FDA Received02/28/2014
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
Patient Outcome(s) Required Intervention;
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