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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 Device Operates Differently Than Expected (2913)
Patient Problems Unspecified Infection (1930); Pain (1994); Seroma (2069)
Event Type  Injury  
Event Description

Received report of the following observations: more post-operative complications in the last twelve months, an increase in seroma formation around the mesh and in-between the mesh and abdominal wall (no specifics on occurrences), increase in post-operative infection; he said he had never had an infection using c-qur and now has seen 4-5 in past 12 months, he is noticing an increase in post-operative pain. The doctor feels that the material is not acting the same and suggested that may be our process has changed since we have been under maquet.

 
Manufacturer Narrative

Investigation: a thorough investigation into this event was not possible as no product lot number, or sample is available for investigation. A review of our complaints database reveals that there have not been any reports received that were attributed to a device malfunction. This report was for more than one event. We have requested more information. As there are no specifics for any of the events one report is being submitted. If any additional information is received, that would impact this report, than a follow up report will be submitted.

 
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Brand NameC-QUR MESH
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH
Manufacturer Contact
theresa morin, manager
5 wentworth dr.
hudson, NH 03051
6038801433
MDR Report Key3485863
MDR Text Key4081402
Report Number1219977-2013-00160
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 10/21/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2013
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 Received10/21/2013
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: 11/13/2013 Patient Sequence Number: 1
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