LAUSR

Fisher's exact test or Chi-squared test. RESULTS: A total of 126,273 RAEs were extracted, of which 22,735 were for male-specific devices and 103,538 were femalespecific. For females, 95.1% of RAEs involved injury, compared to 47.0% in males (p < 0.001). Compared to males, females incurred significantly higher rates of life-threatening outcomes (1.6% vs 0.3%; p<0.001), disabilities (5.2% vs 3.0%; p<0.001), and deaths (0.6% vs 0.2%; p<0.001). Female-specific devices were evaluated by the manufacturer in 5.8% of RAEs, compared to 47.6% of reports involving male-specific devices (p<0.001). CONCLUSIONS: Our report found that a significantly higher number of adverse events and high-grade complications were reported in devices used in women compared to men. Women sustained higher rates of life-threatening outcomes, disabilities and deaths related to medical device. Despite these differences, there was markedly less manufacturer evaluation of female-specific medical devices. Increased scrutiny and assessment of medical devices used in women is needed.