TABLE 4.1 Adverse Event Reports Submitted to FDA, Late 1984 Through December 2004

 

<1985

1985

1986

1987

Manufacturer reportsa

Death

13

585

543

516

Injury

109

9,483

11,738

9,589

Malfunction

28

8,812

7,096

7,596

Other

2

62

10

5

SUBTOTAL

152

18,942

19,387

17,706

User facility reportsb

Death

 

Injury

Malfunction

Other

SUBTOTAL

0

0

0

0

Distributor and importer reportsc

Death

 

Injury

Malfunction

Other

SUBTOTAL

0

0

0

0

Voluntary reportsd

Death

 

31

27

21

Injury

 

345

482

288

Malfunction

 

520

472

349

Other

22,602

2,097

2,170

1,827

SUBTOTAL

22,602

2,993

3,151

2,485

Summary reportse

0

0

0

0

GRAND TOTAL

22,754

21,935

22,538

20,191



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