A Primer to the Structure, Content and Linkage of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) Files

Ensign, Lisa G.; Cohen, K. Bretonnel

doi:10.13063/egems.1253

Cited by 9 publications

(10 citation statements)

References 28 publications

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“…The major limitation of this study stems from the small number of reports included and reporting bias inherent to the MAUDE database, which relies on voluntary reporters to submit adverse events, resulting in potential underreporting of adverse events as well as bias toward reporting of exclusively severe events. 29 As ClariFix is a relatively new device, the database only contains 3 years of reported events, and longitudinal outcome data are unavailable. Furthermore, complication rates cannot be determined as the total number of devices used without complications is unknown.…”

Section: Discussionmentioning

confidence: 99%

Adverse Events Associated With ClariFix Posterior Nasal Nerve Cryoablation: A MAUDE Database Analysis

Singh

Kasle

Torabi

et al. 2021

Otolaryngol.--head neck surg.

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Posterior nasal nerve (PNN) cryoablation is a novel surgical technique used to address chronic rhinitis. The purpose of this study is to review the medical device reports (MDRs) submitted to the Food and Drug Administration’s (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events related to the use of ClariFix, a device designed for office-based cryosurgical ablation of the PNN. A total of 12 adverse events associated with ClariFix from January 2017 to August 2020 were identified and analyzed. The most common adverse events associated with ClariFix PNN cryoablation include epistaxis and nasal swelling. Further studies are needed to clarify whether PNN cryoablation is associated with epistaxis in certain populations.

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Section: Discussionmentioning

confidence: 99%

Adverse Events Associated With ClariFix Posterior Nasal Nerve Cryoablation: A MAUDE Database Analysis

Singh

Kasle

Torabi

et al. 2021

Otolaryngol.--head neck surg.

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“…A large majority of MAUDE reports are submitted by manufacturers, 36 as the number of such reports has increased exponentially over time to nearly 2 thousand being submitted per day. 37 Because most medical and dental devices are approved via the FDA 510(k) process, postmarket surveillance becomes the major mechanism to ensure device and patient safety. Reports made by health care providers to the MAUDE system are entirely voluntary, as contrasted with the required reporting by manufacturers, importers, and device user facilities (defined as being outpatient treatment facility, outpatient diagnostic facility, ambulatory surgery centers, hospitals, and nursing homes).…”

Section: Discussionmentioning

confidence: 99%

“…Despite this possibility, the database represents an underused and arguably unrecognized repository of postmarket safety information for dental devices. A large majority of MAUDE reports are submitted by manufacturers, 36 as the number of such reports has increased exponentially over time to nearly 2 thousand being submitted per day 37 . Because most medical and dental devices are approved via the FDA 510(k) process, postmarket surveillance becomes the major mechanism to ensure device and patient safety.…”

Section: Discussionmentioning

confidence: 99%

Ultrasonic Device Complications in Endodontics: An Analysis of Adverse Events From the Food and Drug Administration Manufacturer and User Facility Device Experience

Rhodes

2021

J Patient Saf

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ObjectivesThe author conducted a study to determine the frequency and types of adverse events associated with endodontic ultrasonic devices as reported to the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.MethodsEndodontic ultrasonic device–related adverse events reported to the MAUDE database from January 1, 2016, to October 31, 2020, were accessed and reviewed.ResultsA total of 1258 adverse event reports were submitted to the FDA MAUDE database, as classified under FDA product code ELC (ultrasonic scaler) during the study period. Among these reports, 403 were specific to the dedicated use of the 2 main types of ultrasonic devices used in endodontic treatment: ultrasonic tip devices and irrigation-related devices. Device malfunction-associated events, consisting primarily of device breakage, comprised 393 of the 1258 adverse event reports, whereas the remaining 10 reports were identified as being patient injury–related reports.ConclusionsThe frequency, root causes, and economic costs of ultrasonic tip device breakage remain largely unstudied. Ultrasonic endodontic device–related adverse events and patient injuries occurring within clinical practice may be underreported at the present time. Consequently, the risks and ultimate impacts to patients from ultrasonic endodontic device breakage, malfunction and unknown cause-related adverse events, and patient injuries during their clinical usage remain largely unknown at the present time. Eight of the 10 patient injury–related reports made to the FDA MAUDE database during the period under study, containing descriptions of varying degrees of injury severity, were associated with an irrigation-related device.

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“…The FDA provides access to MAUDE information through three different tools: (a) an online simple (single‐parameter) interface, (b) advanced (multiparameter) search interface or (c) downloadable data files. These online search engines are extremely convenient; however, information obtained using these interfaces has some restrictions . In our study, we used both the online search interface and the downloadable datasets.…”

Section: Methodsmentioning

confidence: 99%

Descriptive analysis of postmarket surveillance data for hip implants

Pane

Verhamme

Rebollo

et al. 2020

Pharmacoepidemiology and Drug

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Purpose: Recent safety issues involving medical devices have highlighted the need for better postmarket surveillance (PMS) evaluation. This article aims to describe and to assess the quality of the PMS data for a medical device and, finally, to provide recommendations to improve the data gathering process. Methods: A descriptive analysis of medical device reports (MDRs) on the use of MRA, a specific type of hip implant replacement submitted . The number of reports was described as the number of MDRs per unique MDR number and stratified by different variables. The quality was assessed by the level of completeness of the collected PMS data. Results: The total number of reports related to MRA was 2377, and the number of MDRs per year ranged between 84 in 2009 and 452 in 2017. Most of the reports were reported by manufacturer Depuy Johnson & Johnson and were reported by a physician. In 44.9% of the reports, the device problem was reported as "Unknown."When the device problem was known, in the majority of cases, it was related to an implant fracture. The quality of the collected data was assessed as low due to missing information.Conclusion: The underlying data should meet high quality standards to generate more evidence and to ensure a timely signal generation. This case study shows that the completeness and quality of the MDRs can be improved. The authors propose the development of tools to ensure a more dynamic complaint data collection to contribute to this enhancement.

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A Primer to the Structure, Content and Linkage of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) Files

Cited by 9 publications

References 28 publications

Adverse Events Associated With ClariFix Posterior Nasal Nerve Cryoablation: A MAUDE Database Analysis

Adverse Events Associated With ClariFix Posterior Nasal Nerve Cryoablation: A MAUDE Database Analysis

Ultrasonic Device Complications in Endodontics: An Analysis of Adverse Events From the Food and Drug Administration Manufacturer and User Facility Device Experience

Descriptive analysis of postmarket surveillance data for hip implants

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