Dynatronics Dynatron 925 - Reporting Requirements and Warranty

MEDICAL DEVICE REPORTING REQUIREMENTS
DYNATRON® 25 SERIES™ | OPERATOR’S MANUAL 100
Medical Device
Reporting Requirements
Under the Safe Medical Devices Act (SMDA), the manufacturer and distributor are required to report specic incidents to the
FDA. In the event of any applicable incident, you should report details of the incident to the Dynatronics Customer Service
Department at 1-800-874-6251. Reports should be submitted to the manufacturer immediately to allow the manufacturer to
report to the FDA within 2 working days based on the following criteria:
• If you receive information that reasonably suggests a probability that a device caused or contributed to a:
• death
• serious injury, or
• serious illness
• If you receive information that reasonably suggests a device malfunction and a recurrence will probably cause:
• death
• serious injury, or
• serious illness
Denition of serious injury
A “serious injury” is an injury that (1) is life threatening, (2) results in permanent impairment of a body function or permanent
damage to body structure, or (3) necessitates medical or surgical intervention by a health care professional to (i) preclude
permanent impairment of a body function or permanent damage to body structure or (ii) relieve unanticipated temporary
impairment of a body function or unanticipated temporary damage to a body structure.
Reference: Food and Drug Administration, HHS. 21 CFR Ch. 1 (4-1-90 Edition), 803.9 (h).