Concert Medical - Sept. 20, 2016
Issue Date
Sep 20, 2016
Region
Northeast
Category
Device
$117.00
Contact Name
Howard W. Donnelly
Contact Title
President
Address 1
77 Accord Park Dr.
City
Norwell
State
MA
Zip/Postal Code
02061
Country
United States
Inspection Range
Sep 15, 2016 - Sep 20, 2016
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 may have caused or contributed to a death or serious injury.
Investigator(s): James P. Finn