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Message confrimation from the FDA. Everyone go and fill out the form. USA
 
jtbcrum Views: 1,637
Published: 15 years ago
 

Message confrimation from the FDA. Everyone go and fill out the form. USA


Ok. Below is the confirmation that the FDA recieved my report on the Mirena. It says that one or two well-documented case reports may provide an early signal of unexpected problems and lead to additional evaluation. So what happens if they get a hundred well documented complaints about the IUD. Will they remove it from the market? Why don't we see.

B.

Dear Reporter:

Thank you for submitting your report to MedWatch, The FDA Safety
Information and Adverse Event Reporting Program.

This acknowledgement confirms that your report was received. Reports
are added to a postmarketing safety database with similar reports and
reviewed by the FDA’s postmarketing safety staff. Voluntary reports
are essential for ensuring the continued safety of FDA-regulated
products. One or two well-documented case reports may provide an early signal
of unexpected problems and lead to additional evaluation. This may
result in FDA regulatory actions that improve the safety of the products
used in patient care each day.

You might be contacted by an FDA staff member if additional information
on your report
is needed.

Again, thank you for taking the time to submit your report.


Sincerely yours,

MedWatch

 

 
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