Flexicare Medical, Ltd. - Aug. 2, 2018
Issue Date
Aug 02, 2018
Region
HQ
Category
Device
$117.00
Contact Name
Hash Poormand
Contact Title
Managing Director
Address 1
Cynon Valley Business Park, Mount Ash
City
Rhondda Cynon Taff
Zip/Postal Code
CF45 4ER
Country
United Kingdom
Inspection Range
Jul 30, 2018 - Aug 02, 2018
Pages
3
First Observation
An MDR report was not submitted to FDA 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): Stephen D. Eich