Terumo Medical Corp. - Sept. 12, 2013
Issue Date
Sep 12, 2013
Region
Central
Category
Device
$117.00
Contact Name
Harry S. MacArthur
Contact Title
VP of Operations
Address 1
950 Elkton Blvd.
City
Elkton
State
MD
Zip/Postal Code
92921-5322
Country
United States
Inspection Range
Sep 04, 2013 - Sep 12, 2013
Pages
2
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): Joseph A. Morkunas