An Analysis of the Food and Drug Administration Maude Database for Approved Devices in Obstetrics and Gynecology
Sign Up to like & getrecommendations! Published in 2019 at "Journal of Minimally Invasive Gynecology"
DOI: 10.1016/j.jmig.2019.09.731
Abstract: Study Objective To evaluate the accuracy of the postmarket surveillance process in the MAUDE database for devices approved via the Food and Drug Administration (FDA) premarket (PMA) and 510(k) approval processes and used in Obstetrics… read more here.
Keywords: maude database; death; obstetrics; death reports ... See more keywords
Major Complications and Adverse Events Related to the Injection of the SpaceOAR® Hydrogel System Before Radiotherapy for Prostate Cancer: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database.
Sign Up to like & getrecommendations! Published in 2019 at "Journal of endourology"
DOI: 10.1089/end.2019.0431
Abstract: PURPOSE The SpaceOAR® is a Food and Drug Administration-approved hydrogel injection used to create space between the prostate and rectum during prostate radiotherapy. It has shown to significantly reduce the rectal radiation dose with lower… read more here.
Keywords: prostate; maude database; system; manufacturer ... See more keywords
0509 Adverse Event Reports for CPAP, HNS and Oral Devices: An FDA MAUDE Database Analysis
Sign Up to like & getrecommendations! Published in 2023 at "SLEEP"
DOI: 10.1093/sleep/zsad077.0509
Abstract: This investigation analyzes adverse event reports (AERs) from the FDA MAUDE database for Continuous Positive Airway Pressure (CPAP), Hypoglossal Nerve Stimulation (HNS) and Oral Appliance Therapy (OAT) devices. The FDA defines adverse events as undesirable… read more here.
Keywords: event reports; event; maude database; adverse event ... See more keywords
Are all cages created equal? Analysis of Cervical Cage Malfunctions Using FDA MAUDE Database.
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DOI: 10.1097/brs.0000000000004638
Abstract: STUDY DESIGN Retrospective case series. OBJECTIVE To characterize failure rates of cervical cages based on manufacturer and design characteristics using the nationwide database of reported malfunctions. SUMMARY OF BACKGROUND DATA The Food and Drug Administration… read more here.
Keywords: manufacturer; cage; failure; maude database ... See more keywords
Adverse Events Associated with Femtosecond Laser-Assisted Cataract Surgery Reported to the FDA MAUDE Database.
Sign Up to like & getrecommendations! Published in 2021 at "Journal of cataract and refractive surgery"
DOI: 10.1097/j.jcrs.0000000000000739
Abstract: PURPOSE To report real-world complications associated with femtosecond laser-assisted cataract surgery (FLACS). SETTING De-identified database. DESIGN Retrospective review of adverse events associated with FLACS reported to the Food and Drug Administration's (FDA) Manufacturer and User… read more here.
Keywords: maude database; femtosecond laser; database; adverse events ... See more keywords
"Exploring the Patient Narrative for Breast Implant Illness: A 10-Year Review of the FDA MAUDE Database".
Sign Up to like & getrecommendations! Published in 2022 at "Plastic and reconstructive surgery"
DOI: 10.1097/prs.0000000000009694
Abstract: INTRODUCTION There is growing recognition of a condition known as Breast Implant Illness (BII). Very little information exists about the diagnosis and natural history of BII. To better understand the patient experience, we surveyed the… read more here.
Keywords: implant illness; breast implant; fda maude; maude database ... See more keywords