C.R. Bard, Inc., Urological Division - 7/25/2012
Issue Date
Jul 25, 2012
Region
Southeast
Category
Device
$117.00
Address 1
8195 Industrial Blvd Ne
City
Covington
State
GA
Zip/Postal Code
30014
Country
United States
Inspection Range
Jul 16, 2012 - Jul 25, 2012
Pages
2
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise 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): Trang N. Cox and Kimberly C. Delk-Brooks