Trimedyne, Inc. - July 22, 2011
Issue Date
Jul 22, 2011
Region
Pacific
Category
Device
$117.00
Address 1
25901 Commercentre Dr.
City
Lake Forest
State
CA
Zip/Postal Code
92630-8805
Country
US
Inspection Range
Jul 18, 2011 - Jul 22, 2011
Pages
3
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): Francis J. Eng