Aesculap, Inc. - Sept. 14, 2016
Issue Date
Sep 14, 2016
Region
Southwest
Category
Device
$117.00
Contact Name
Robin M. Fatzinger
Contact Title
VP Regulatory Affair and Quality Assurance
Address 1
615 Lambert Pointe Dr.
City
Hazelwood
State
MO
Zip/Postal Code
63042
Country
United States
Inspection Range
Sep 12, 2016 - Sep 14, 2016
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 may have caused or contributed to a death or serious injury.
Investigator(s): Eric M. Padgett