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Table 3 Rate of population of critical fields in initial reports

From: Quality analysis of manufacturer's incident reports regarding medical devices

Field

%

Manufacturer information

Name

98.88

E-mail

84.69

Country

97.58

Authorised Representative Information

Name

91.17

E-mail

90.72

Submitter’s information

Name

96.06

E-mail

94.71

Medical device information

Commercial name brand name/make

98.10

Serial number(s) (if applicable)

74.65

Lot/batch number(s) (if applicable)

71.30

Incident Information

Date the incident occurred

70.50

Incident description narrative

99.13

Manufacturer’s awareness date

98.70

Medical device current location/disposition (if known)

66.26

Patient information

Patient outcome

87.98

Healthcare facility information

Name

83.14

E-mail

43.88