TABLE 4.2 FDA Adverse Event Reports Involving Individuals Under Age 21 (1999–2004)a

 

1999

2000

2001

2002

2003

2004

TOTAL

Manufacturer

Death

29

39

94

101

96

92

451

Injury

513

483

838

948

1,040

1,371

5,193

Malfunction

523

540

795

1,279

980

438

4,555

Other

185

162

195

147

173

190

1,052

SUBTOTAL

1,250

1,224

1,922

2,475

2,289

2,091

11,251

User Facility

Death

17

10

23

19

14

12

95

Injury

134

131

172

107

76

78

698

Malfunction

69

41

61

48

70

64

353

Other

28

17

22

32

39

32

170

SUBTOTAL

248

199

278

206

199

186

1,316

Importer

Death

0

1

1

0

0

0

2

Injury

7

1

10

43

53

24

138

Malfunction

11

3

13

73

115

42

257

Other

4

19

6

8

2

0

39

SUBTOTAL

22

24

30

124

170

66

436

Voluntary

Death

7

9

9

15

12

15

67

Injury

86

86

111

141

115

144

683

Malfunction

84

70

133

135

138

156

716

Other

25

31

27

35

38

26

182

SUBTOTAL

202

196

280

326

303

341

1,648

GRAND TOTAL

1,722

1,643

2,510

3,131

2,961

2,684

14,651

aNot all reports include information on patient age.

SOURCE: Division of Surveillance Systems, CDRH.

about the device (e.g., brand and model number and even manufacturer) may not have been documented. A later section of this chapter returns to these and other limitations of adverse event reporting programs.

When FDA receives an adverse event or device malfunction report from a manufacturer or other party, it (actually a contractor) checks the report, codes certain information if it has not been coded already by the reporter, and enters the report into the database.2 FDA has developed codes for both clinical outcomes (e.g., cerebral hemorrhage) and device outcomes (e.g.,

2  

The description of the event review process and the discussion of analysis priorities are based on an April 15, 2004, presentation to the committee by Thomas P. Gross, M.D., Director, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, CDRH, and a June 24, 2004, presentation by Rosalie Bright, Epidemiologist, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, CDRH (see, Gross 2004; Bright, 2004).



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