Category: Medical Device Reports (MDRs)

A 2015 ‘Superbug’ Outbreak in North Carolina: Were Contaminated Duodenoscopes to Blame?

June 15, 2015 — The Mountain Xpress, a local newspaper in Asheville (NC), reported earlier this week that two patients died in February at a hospital in North Carolina “from…

USA TODAY Investigation: “Reports to Feds on deadly bacteria outbreaks arrived late”

Medical device reports — or, MDRs, which manufacturers of duodenoscopes and other medical devices are required to submit to the FDA within 30 days of learning that their device might…

THE SEATTLE TIMES: Senator Patty Murray urges FDA to Act to Prevent “Superbug” Infections Following GI Endoscopy

The February 4, 2015, edition of The Seattle Times newspaper publishes the article: “After Virginia Mason superbug, Patty Murray urges FDA action” The article’s sub-title states: “U.S. Sen. Patty Murray…