Mediwatch UK Ltd. - Nov. 4, 2011
Issue Date
Nov 04, 2011
Region
HQ
Category
Device
$117.00
Address 1
Lumonics House, Valley Dr.
City
Rugby, Warwickshire
Zip/Postal Code
SG120
Country
GB
Inspection Range
Oct 31, 2011 - Nov 04, 2011
Pages
7
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): Donna L. Tartaglino Besone