Prism Medical USA, Inc. - May 2, 2013
Issue Date
May 02, 2013
Region
Southwest
Category
Device
$117.00
Contact Name
Agustin X. Garcia de Paredes
Contact Title
Manager, North American Quality Assurance & Regulatory Affairs
Address 1
45 Progress Pkwy.
City
Maryland Heights
State
MO
Zip/Postal Code
63043-3701
Country
United States
Inspection Range
Apr 24, 2013 - May 02, 2013
Pages
3
First Observation
An MDR report was not submitted within 30 days of receiving or becoming otherwise aware of information that reasonable suggests that a marketed device has malfunctioned and would be likely to cause or contribute to death or serious injury if the malfunction were to recur.
Investigator(s): Steven D. Kehoe and Thuy Thanh Nguyen