Relative risks of reported serious injury and death associated with hemostasis devices by gender

Purpose To assess relative risks by gender of reported serious injuries and deaths associated with the use of hemostasis devices, stratified by year of report, type of injury, and type of device. Methods Reports from the Food and Drug Administration's Medical Device Reporting system and Nationa...

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Bibliographic Details
Published in:Pharmacoepidemiology and drug safety 2003-04, Vol.12 (3), p.237-241
Main Authors: Tavris, Dale R., Gallauresi, Beverly, Rich, Suzanne, Bell, Carlos
Format: Article
Language:English
Subjects:
Angioplasty, Balloon, Coronary - adverse effects
cardiac catheterization
Databases, Factual
Equipment and Supplies - adverse effects
Equipment Safety
Female
Femoral Artery
Hematoma - etiology
Hematoma - mortality
Hemorrhage - etiology
Hemorrhage - mortality
hemostasis device
Hemostatic Techniques - adverse effects
Hemostatic Techniques - instrumentation
Humans
Infection - etiology
Infection - mortality
Male
medical device reporting
National Center for Health Statistics (U.S.)
Risk Assessment
Sex Factors
Time Factors
United States - epidemiology
United States Food and Drug Administration - statistics & numerical data
Wounds and Injuries
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Summary:Purpose To assess relative risks by gender of reported serious injuries and deaths associated with the use of hemostasis devices, stratified by year of report, type of injury, and type of device. Methods Reports from the Food and Drug Administration's Medical Device Reporting system and National Center for Health Statistics data on use of cardiac catheterization were used to estimate relative risks of reported serious injuries and deaths by gender. Results Estimated risks of reported serious injuries and deaths associated with hemostasis devices were two to three times greater in females than in males for hemorrhage and hematoma (p 
ISSN:1053-8569
1099-1557
DOI:10.1002/pds.802