medICal devICe reporTIng requIremenTs
DYNATRON® T3™ HI-LO TREATMENT TABLE & T4™ TRACTION TABLE | OPERATOR’S MANUAL REV. 10 | 4/4/2018
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Medical Device
Reporting Requirements
Under the Safe Medical Devices Act (SMDA) of November 1990, the manufacturer and distributor are required to report
specific 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
b. serious injury, or
c. serious illness
If you receive information that reasonably suggests a device malfunction and a recurrence will probably cause:
a. death
b. serious injury, or
c. serious illness
Definition 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, 21 CFR 803.9 (h).
