Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERVASCULAR HEMAGARD VASCULAR GRAFT; VASCULAR GRAFT PROSTHESIS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTERVASCULAR HEMAGARD VASCULAR GRAFT; VASCULAR GRAFT PROSTHESIS Back to Search Results
Lot Number 13J26
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Blood Loss (2597)
Event Type  malfunction  
Event Description
During a vascular surgery, the graft was reported to bleed more than usual.The graft remained implanted and the surgery was completed without any adverse event for the pt.No add'l info on the product serial number could be obtained at this time.
 
Manufacturer Narrative
No device eval was performed since the device was not returned to the manufacturer and the product identifier was not provided.No review of the device history record was done since the product identifier was not provided.No conclusion can be drawn.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEMAGARD VASCULAR GRAFT
Type of Device
VASCULAR GRAFT PROSTHESIS
Manufacturer (Section D)
INTERVASCULAR
zi athelia 1
laciotat cedex 1360 5
FR  13605
Manufacturer Contact
pascal framond
zone industrielle athelia i
laciotat 13605
FR   13605
42084646
MDR Report Key4360664
MDR Text Key5236118
Report Number1640201-2014-00038
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 12/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2018
Device Lot Number13J26
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-