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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL FLIXENE GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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ATRIUM MEDICAL FLIXENE GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Fever (1858); Pain (1994); Swelling (2091); Thrombosis (2100)
Event Type  Injury  
Manufacturer Narrative
A complete investigation was not able to be performed as no product code, lot number, or sample was provided.Per the study, a high percentage of avbg with localized infection can be rescued.
 
Event Description
Received an study titled "rescue of infected av grafts for haemodialysis access".The abstract was to review treatment options for graft infections.Forty-six patients with infected avbg were reviewed between january 2003 and december 2009.Per the abstract adverse events included swelling, pus, pain, fever, draining sinus and thrombosis.
 
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Brand Name
FLIXENE GRAFT
Type of Device
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Manufacturer (Section D)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key7340870
MDR Text Key102451881
Report Number3011175548-2018-00257
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/15/2018
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 02/26/2018
Initial Date FDA Received03/15/2018
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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