Aim: To assess the quantity and quality of incident reports on medical devices by health care professionals from 2012 to 2021 and evaluate the effect of reporting on manufacturers' post-market surveillance.
Methods: Eighty-five incident reports were scored according to a self-developed evaluation system, and categorized as excellent, good, medium, qualified, and unqualified. The completeness of data in critical fields was assessed. For each report, the type and city of the reporter, and medical device risk class were extracted to calculate the frequency of report occurrence per risk class and outcomes for reportable reports.
Results: The number of reports received from health care professionals was low; the highest number of reports in a year was 17. The majority of reports were deemed as unqualified (61.18%) and only 4.71% as excellent. Still, 67.65% of incident reports importantly affected the manufacturer's post-market surveillance, either as added information that contributes to risk monitoring or directly triggering a field safety corrective action.
Conclusion: The number of total reports and reports per year shows extensive underreporting in Croatia, and the quality of the provided reports is insufficient.