Vigilance - incident found in an article

med_cert

Involved In Discussions
#1
Hello,

if manufacturer becomes aware about an incident by literature review (the article has been released few months ago, the article states that this incident occured more than 3 years ago), is this sufficient proof that "an event has occured" (one of three basic reporting criteria) and it should be reported (innitial report) without any additional information (there is not enough info in the article - manufacturer immediately contacted authors), or manufacturer should wait the confirmation and additional information by the author of this article?
 
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twanmul

Involved In Discussions
#2
If you don't have sufficient detail to investigate and/or report, then surely you need to await information from the author(s) of the article.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#3
I would follow your SOP for receiving a complaint. Exercise the required effort from your SOP to respond to the complaint properly.
 
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