MED-EL Elektromedizinische Gereate, Gmbh - May 7, 2015
Issue Date
May 07, 2015
Region
HQ
Category
Device
$117.00
Contact Name
Ingeborg Hochmair
Contact Title
Chief Executive Officer (CEO)
Address 1
Furstenweg 77a
City
Innsbruck
Zip/Postal Code
6020
Country
Austria
Inspection Range
May 04, 2015 - May 07, 2015
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 contriibute to a death or serious injury if the malfunction were to recur.
Investigator(s): Raffi B. Papazian