Provent Sleep Therapy LLC - Jan. 3, 2018
Issue Date
Jan 03, 2018
Region
Northeast
Category
Device
$117.00
Contact Name
Jeremy S. Brockmann
Contact Title
Vice President
Address 1
125 Tolman Ave.
City
Leominster
State
MA
Zip/Postal Code
01453
Country
United States
Inspection Range
Jan 02, 2018 - Jan 03, 2018
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): Stephen C. Smith