FDA adverse event

  1. 478 Posts.
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    I may have missed something along the way, but it surprised me today to read about an FDA adverse event from about a year ago, in which an unnamed facility advised the FDA that the heat from the trophon disinfection units was loosening the epoxy that held its ultrasound probes together, allegedly resulting in 6 probes falling apart and 12 trophon units being returned to Nanosonics. http://fdazilla.com/maude/adverseevent/3853109

    Again, I may have missed something along the way, but I haven't seen any advice from management to NAN shareholders about this event. At the very least, it seems reasonable that management should have advised shareholders at the time, of the circumstances surrounding the FDA adverse event, including whether the disintegration of the probes in question was due to trophon disinfection of non-approved probes, misuse of the trophon disinfection units, or a design flaw in the trophon technology.

    zeno9
    Last edited by zeno9: 05/05/15
 
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