![]() Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices. MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices.Please note that the MAUDE web search feature is limited to adverse event reports within the past 10 years.Please see the MDR Data Files webpage for Device Experience Network (DEN) and Alternative Summary Report (ASR) data received by the FDA. Because of this, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.Īlthough MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. The new bed is being manufactured in Hays, Kansas.Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. Sizewise, based in Kansas City, has a thousand employees nationally. But Westbrook says it should cut down on workman’s comp claims and the need for two or more caregivers to re-position a patient. ![]() It sells for around $11,000 compared to around $8,000 for a standard model. That’s before you have to change the sheet. “The sheet glides up into a drive unit and it wraps in a circle into the drive unit and you have eight to 10 re-positionings,” said Mary Nell Westbrook. The chief marketing officer describes the special bed sheet as a little magic carpet ride. The company’s new Hercules model bed automatically moves patients weighing up to 750 pounds. “What I can do with the touch of two buttons is pull the patient up in bed,” said Theibault. Sizewise says it has an innovative solution to this weighty issue. “You want to help them and then you’re too big and you can’t move,” said Mercer. Kevin Mercer, who says he weighs more than 300 pounds, felt bad when caregivers moved him after hip surgery. It’s a common way caregivers suffer acute or cumulative injuries to the back, shoulder and neck. “Then we’re gonna take the sheet,” she said as she and a co-worker rolled a sheet and demonstrated how re-positioning is done manually. ![]() She’s also worked in hospitals where patients slide down in bed and need to be moved up for comfort and to prevent bed sores. Nurse Erica Theibault works for Sizewise Worldwide, a medical equipment company. A Kansas City-based company is rolling out a novel bed, one it says reduces risks for caregivers and patients. ![]() More than a third of American adults are obese, so hospitals are needing to invest in equipment to better accommodate bigger patients. Please look at the time stamp on the story to see when it was last updated. This is an archived article and the information in the article may be outdated. ![]()
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