Quality analysis of manufacturer's incident reports regarding medical devices

Table 6 Number and percentage of initial and final reports per category

	Number of EU-based initial reports	%	Number of non-EU-based initial reports	%	Number of EU-based final reports	%	Number of non-EU-based final reports	%
Excellent	98	21.03	45	40.18	262	57.21	73	67.59
Good	246	52.79	51	45.54	50	10.92	6	5.56
Medium	71	15.24	10	8.93	62	13.54	7	6.48
Qualified	32	6.87	4	3.57	12	2.62	1	0.93
Unqualified	19	4.08	2	1.79	72	15.72	21	19.44

Median quality of the initial reports from manufacturers based on EU countries and third countries were 84.62% and 87.64%, respectively; the distributions in the two groups differ significantly (Mann–Whitney U = 38,598, n1 = 466, n2 = 112, p = 0.0001 two-tailed)
Median quality of the final reports from manufacturers based on EU countries and third countries were 90.91% and 91.67%, respectively; the distributions in the two groups do not differ significantly (Mann–Whitney U = 30,191, n1 = 458, n2 = 108, p = 0.7746 two-tailed)

ISSN: 2052-3211