Alseal - June 9, 2016
Issue Date
Jun 09, 2016
Region
HQ
Category
Device
$117.00
Contact Name
Jean- Francois Delforge
Contact Title
President and CEO
Address 1
2 rue Professeur Paul Milleret
City
Besancon
State
Doubs
Zip/Postal Code
25000
Country
France
Inspection Range
Jun 06, 2016 - Jun 09, 2016
Pages
4
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): Catherine J. Laufmann