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“Medical device” is one of the health products that are important in improving the quality of life of patients. However, medical devices may cause adverse effects for user of medical devices. Methodology: This research is a retrospective study from January 2017 – December 2018. The data were collected and analyzed from Device defective & adverse event report using percentage, mean and statistic for Fisher Exact Test. Results: A total of 180 samples of the group of adverse effects-caused medical devices were enrolled: male, n = 96 (53.33%); female, n = 84 (46.67%). The average age of these samples is 61 years (SD 15.66). This study found that the most adverse reactions-caused medical device is implantable medical device, 69 cases (38.33%). It also showed the 156 medical staffs were medical device users during the incident (86.67%) which is the first use of 171 cases (95.00%). The incidence of the severity of the adverse effects were mostly found to be mild, 111 cases (61.67%), and the group of medical devices correlated with the level of adverse effects occurring with statistically significance at the level of 0.05 (p-value = 0.025). The study also found that ophthalmic and optical devices, active implantable devices and implantable devices caused the most adverse effects occurred from using medical devices which accounted for 40.00%, 30.95% and 7.68%, respectively. Conclusion: Therefore, relevant departments have the opportunities to develop rules & regulations in order to reduce the severity of adverse events from the use of medical devices, by focusing on legal issues, policy on medical device especially in the matter of quality standard and safety of medical device of factors that are found to be related to the severity of adverse effects from the use of medical devices.
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