Covidien - Aug. 27, 2014
Issue Date
Aug 27, 2014
Region
Southeast
Category
Device
$117.00
Contact Name
Marisol Sanchez Perez
Contact Title
Site Director
Address 1
201 Sabanetas Industrial Park
City
Ponce
State
PR
Zip/Postal Code
00716
Country
United States
Inspection Range
Jul 23, 2014 - Aug 27, 2014
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): Miguel G. Manzano