[ SHOWGSD-L ] FDA Warns of Possible Danger with Animal Vaccine Device

From: Hope Stormy <stormy435@xxxxxxxxx>
To: gsd showlist <showgsd-l@xxxxxxxxxxxxx>
Date: Sat, 3 Sep 2011 08:50:44 -0700
FDA Warns of Possible Danger with Animal Vaccine Device

September 2, 2011

The Food and Drug Administration is warning veterinarians and pet
owners, particularly cat owners, of the possible risk of fractures with
the Vet Jet^(TM) transdermal vaccination system device. The device, made
by Bioject, Inc., is sold exclusively as the delivery system for the
Merial product, PUREVAXÂ® Recombinant Feline Leukemia Vaccine. The  
device
delivers the leukemia vaccine through the skin to cats.

FDA is aware of three recent adverse event reports involving the use of
the Vet Jet^(TM) device in kittens. In two of the cases, the user failed
or may have failed to properly lock the nozzle into the device before
using it. The nozzle subsequently dislodged at the time of vaccination,
causing a fracture of the femur (the thigh bone).

Merial is fully investigating the three cases. The company is also
revising the "Instructions for Use" for the Vet Jet^(TM) device to
stress that users need to securely lock the nozzle into the device. In
addition, Merial is sending a letter to all Vet Jet^(TM) device users
urging them to carefully follow the nozzle locking procedure.

FDA asks veterinarians and pet owners who want to report problems with
the Vet Jet^(TM) device to first contact Merial. They can also report
problems to FDA by submitting FORM FDA 1932a
<http://www.fda
gov/downloads/AboutFDA/ReportsManualsForms/Forms/AnimalDrugForms/ 
UCM048817
pdf>^1
.. 
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[ SHOWGSD-L ] FDA Warns of Possible Danger with Animal Vaccine Device

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