MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
We are encouraging the DES exposed to report their effects from DES Exposure.
You will receive an acknowledgment confirming that your report was received. Reports are added to a post marketing safety database with similar reports and reviewed by the FDA's post marketing 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 should be contacted for follow-up by FDA if additional information on this report is needed in our evaluation process. This response may take awhile.
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