F.P. Rubinstein Y Cia SRL - Dec. 17, 2015
Issue Date
Dec 17, 2015
Region
HQ
Category
Device
$117.00
Contact Name
Federico P. Rubinstein
Contact Title
Director
Address 1
Calle David Luque 519
City
Cordoba
Zip/Postal Code
X5004AKM
Country
Argentina
Inspection Range
Dec 14, 2015 - Dec 17, 2015
Pages
8
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): Marc S. Neubauer