DB 2008(02) Adverse Incident Reports 2007

This annual report provides an overview of medical device related adverse incident reports received by the MHRA in 2007, and records recent developments in adverse incident reporting. It also includes an update from the Device Technology and Safety (DTS) division’s three specialist technical units, background information on incident reporting procedures, a summary of the year’s key statistics and a brief analysis of customer survey responses.

In 2007 the MHRA received 8.26% more adverse incident reports than in the previous year. The 8,634 total for 2007 is almost at the peak levels seen during 2002-2004 and is 19% higher than the total for 2000.

The following actions were taken as a result of investigations made:

• 100 Medical Device Alerts (MDAs) were issued
• 86 notifications were shared with Competent Authorities in EU member states
• 674 manufacturer’s field safety corrective actions and 92 other manufacturer’s field actions were undertaken
• 206 cases requiring the provision of advice on safer device use or improved staff training were identified
• 397 manufacturer undertakings to improve designs, manufacturing processes and quality systems.