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2004 March Report of the Auditor General of Canada

March 2004 Report—Chapter 2

Exhibit 2.8—Reporting adverse events of a medical device in Canada, the U.S., and the UK, 2002

  

Canada

U.S.

UK

Mandatory—manufacturer

730

141,000

2,000

Mandatory—hospitals

0

2,500

0

Voluntary

270

3,500

6,750

Total

1,000

147,000

8,750

Population (millions)

30

288

59

Rate per million

33

510

148

 

Source: Health Canada, U.S. Food and Drug Administration, UK Medicines and Healthcare Products Regulatory Agency