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SIGH Pediatric Developmental Program REFERRAL FORM Thank you for your referral. In order to best serve your patient, please complete this form as thoroughly as possible. Fax completed form to (415)
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MDAC SFGH stands for Medical Device Adverse Event Code for Serious Fatalities and Hospitalizations. It is a form used to report adverse events related to medical devices.
Manufacturers, importers, and device user facilities are required to file MDAC SFGH when they become aware of an adverse event related to a medical device.
MDAC SFGH can be filled out electronically through the FDA's MAUDE database or submitted via mail or fax using the FDA Form 3500A.
The purpose of MDAC SFGH is to track and monitor adverse events related to medical devices in order to ensure patient safety.
Information such as patient demographics, device information, adverse event description, and outcomes must be reported on MDAC SFGH.
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