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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR TACSHIELD; MESH, SURGICAL, POLYMERIC
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ATRIUM MEDICAL CORP. C-QUR TACSHIELD; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Event Description
A hospital reported three infection cases following hernia repair.
 
Manufacturer Narrative
The actual product was not returned and there were neither product code, description or product lot number provided, the complaint could not be fully investigated.Several attempts were made to collect additional details without any success.The mesh product is provided sterile to the user.The product is sterilized using a traditional 3-step ethylene oxide (eo) cycle that delivers a 10-6 sterility assurance level (sal).This cycle is validated using biological indicators (bis) per the 'overkill method' outlined in ansi/aami/iso 11135-1:2007, sterilization of health care products.Related mdr's 1219977-2014-00405 and 00407.
 
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Brand Name
C-QUR TACSHIELD
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer Contact
theresa morin
5 wentworth dr.
hudson, NH 03051
6038645237
MDR Report Key4381498
MDR Text Key16895579
Report Number1219977-2014-00406
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 Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 12/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2014
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 Received12/17/2014
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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