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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR MESH (4X6)

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ATRIUM MEDICAL CORP. C-QUR MESH (4X6) Back to Search Results
Model Number 31528
Device Problem Fracture (1260)
Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Swelling (2091); Impaired Healing (2378)
Event Date 11/11/2011
Event Type  Other  
Manufacturer Narrative
Since no product was returned for evaluation, the complaint cannot be confirmed. Following investigation, our conclusion is that the probable root cause is unknown due to not enough information available to make a determination. The device history records for the batch were reviewed. All manufacturing and quality assurance testing was carried out in accordance with our standard procedures. The device history record for this batch shows that the product met its specifications at the time of release to distribution and there are no similar incidents against this batch.
 
Event Description
Fda medwatch (b)(4), received 07/27/2012 on (redacted) 2011, patient was implanted for incisional hernia repair with an atrium c-qur polypropylene surgical mesh with omega 3 fatty acid bio-absorbable coating. After much pain and swelling around incision site for 9 weeks, additional surgery took place on (redacted) 2011 to remove the atrium c-qur mesh. Fatty acid coating came off in a few weeks and left bare polypropylene surgical mesh in contact with otherwise healthy tissue and caused a significant foreign body reaction and inflammation and a "cottage cheese like substance" (not infection) which surrounded the mesh. As per the surgeon's statement and surgical report the mesh never allowed healing, mesh fractured and was very poorly incorporated. Previously otherwise healthy tissue was removed, including previously healthy muscle tissue was removed because of damage done by atrium c-qur. Because of the previously healthy tissue removal surrounding the atrium c-qur, surgeon was left with only option to perform a retro rectus repair implanting 15x15 ethicon prolene mesh. Subsequent life threatening infection, prolonged hospitalization, then 6 weeks of home iv infusion of vancomycin, additional 5 weeks of oral vancomycin. Third surgery is now required to remove ethicon prolene mesh. Patient is now had has been on heavy pain medication since (redacted) 2011, has additional numerous health problems which arose after implant of atrium c-qur.
 
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Brand NameC-QUR MESH (4X6)
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 Key2695280
MDR Text Key10025617
Report Number1219977-2012-00018
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
Reporter Occupation
Type of Report Initial
Report Date 08/08/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2012
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2014
Device Model Number31528
Device Catalogue Number31528
Device Lot Number10740287
Was Device Available for Evaluation? No
Date Manufacturer Received07/27/2012
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2011
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: 08/08/2012 Patient Sequence Number: 1
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