Study of Adverse Events Associated With the Use of Medical Devices Reported Under the Materiovigilance Programme of India in a Tertiary Care Teaching Hospital.

Abstract

Background Medical device adverse events (MDAEs) are critical incidents in healthcare systems that can lead to patient harm, necessitating thorough investigation and management. This study aims to comprehensively analyse MDAE reports collected over six months at a Medical Device Management Centre (MDMC). The investigation focuses on various aspects, including gender distribution, age demographics, types of medical devices implicated, department-wise distribution within hospitals, risk classifica