Gynetech PTY, Ltd. - Sept. 2, 2016
Issue Date
Sep 02, 2016
Region
HQ
Category
Device
$117.00
Contact Name
Brett M. Telford
Contact Title
Managing Director
Address 1
122 Balmain St.
City
Richmond
Zip/Postal Code
3121
Country
Australia
Inspection Range
Sep 01, 2016 - Sep 02, 2016
Pages
8
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): Ashley A. Mutawakkil