DeRoyal Industries, Inc. - March 27, 2015
Issue Date
Mar 27, 2015
Region
Southeast
Category
Device
$117.00
Contact Name
Elizabeth R. Reed
Contact Title
Senior Director of Quality & Regulatory
Address 1
200 Debusk Ln.
City
Powell
State
TN
Zip/Postal Code
37849-4703
Country
United States
Inspection Range
Mar 23, 2015 - Mar 27, 2015
Pages
4
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Wendy R. Blame and Matthew R. Mcnew