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Complete and submit this form to the designated Safety Office within 3 working days of the accident/Incident. 3. Please remember to sign and date the form. 4.Read more
Select State of the event to determine reporting requirements. The fields indicated with an asterisk (*) are required to complete your submission. State: *.Read more
A user facility is required to report a device-related death or a device-related serious injury to the manufacturer and to report a device-related death to FDA.Read more