A product issue could lead to serious health consequences, including loss of consciousness, bleeding, fluid buildup around the heart and death.
All of the issues that ECRI calls out on its list are preventable, so device manufacturers and healthcare providers should take serious note.
Medtech manufacturers must continue to embrace collaboration and transparency.
Risks related to balloon deflation, fragmentation and detachment could lead to serious adverse events, including death.
The device will no longer be available after December 31, 2018.
When ferromagnetic objects enter an MRI suite, they become a serious hazard – here’s how to prevent them from getting in.
Failing to report serious patient injuries will win you a warning letter.
The document clarifies the MDR regulation and reporting requirements for medical device companies.
Few things motivate FDA faster than a significant number of adverse events, especially deaths.