Dannik - Aug. 12, 2022
Issue Date
Aug 12, 2022
Region
Southeast
Category
Device
$117.00
Contact Name
Olga L. Haberland
Contact Title
President
Address 1
3201 E. Colonial Dr.
Address 2
Ste. M3
City
Orlando
State
FL
Zip/Postal Code
32803-5167
Inspection Range
Aug 08, 2022 - Aug 12, 2022
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 injmy if the malfunction were to recur.
Investigator(s): Shafiq S. Ahadi