A review of laser injuries as reported through the MDR system Available to Purchase

As part of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act and as redefined in the safe Medical Device Act of 1990, manufacturers and other designated healthcare facilities are required to report instances of serious or potentially serious injury resulting from medical device use. A number of reports have been published in recent years attempting to evaluate this data base. The purpose of this review is to re-examine the MDR data for the past 5 years to either identify patterns of injury or establish if the injury reports are the result of user error rather than device failure. Because this report is focussing on MDR data, it is possible that injury reports in other FDA data bases will be missed. It is hoped that examining data covering such an extended period will provide sufficient numbers of incidents so that some logical injury groupings can be identified and the cause of the injury evaluated.