Fournitures Hospitalieres Industrie - Sept. 6, 2018
Issue Date
Sep 06, 2018
Region
HQ
Category
Device
$117.00
Contact Name
Philippe R. Veistroffer
Contact Title
General Manager
Address 1
Zone Industrielle de Kernevez, 6 rue Nobel
City
Quimper
State
Finistere
Zip/Postal Code
29000
Country
France
Inspection Range
Sep 03, 2018 - Sep 06, 2018
Pages
5
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): David J. Gasparovich