Anyone using any electronic medical device should keep this web address (url) handy if G-d forbid they need it…
One of the reasons so many of our problems with companies and equpment do NOT get addressed is that we report to the company and think they are very good "citizens" and will immediately follow the law and report any potentially serious problems ot the FDA. it turns out that many companies (I am not venturing to guess who or what, can only speak of the cases and companies I know) are NOT reporting the events, they are not collecting the followup information that should be provided to FDA (for example - did the event result in a hospitalization or a doctor call or visit? Did it result in an Emergency Squad call? what remedial steps were necessary to address the result of the event?
I have had a pump for over thirty years and have never had to obtain this address or use it before. When I looked at the FDA site and pulled up the company and reported problems, the vast majority of cases I kow about are not even listed!!
If you are having a problem with a pump, meter, sensor or any other medical device, you should report any adverse effects you have to this web site and keep records. It is the ONLY way that we will be able to get the comanies that are supposed to be taking care of us to comply with their federal requirements on reporting and fixing of problems!!
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