Western / Scott Fetzer Company - May 27, 2010
Issue Date
May 27, 2010
Region
Central
Category
Device
$117.00
Address 1
875 Bassett Rd.
City
Westlake
State
OH
Zip/Postal Code
44145-1142
Country
US
Inspection Range
May 18, 2010 - May 27, 2010
Pages
2
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): Mary E. Storch