The Utility of the MAUDE Database for Osseointegrated Auditory Implants

Coelho, Daniel H.; Tampio, Alex J F

doi:10.1177/0003489416674962

Cited by 12 publications

(18 citation statements)

References 14 publications

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“…Though MAUDE contains a wealth of useful information, it lacks the proper mechanisms to allow for a clear systematic analysis . Since there is no required structure for events reporting, the reporting party can choose any format they please, leading to wide variability between reports that can lead to ambiguity regarding the nature of the adverse event.…”

Section: Discussionmentioning

confidence: 99%

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Investigating Complications Associated With Occipital Nerve Stimulation: A MAUDE Study

Doran

Ward

et al. 2018

Neuromodulation: Technology at the Neural Interface

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Section: Discussionmentioning

confidence: 99%

“…The MAUDE data base has been utilized to analyze adverse events in varied surgical subspecialties (8)(9)(10)(11)(12)(13). MAUDE studies are meant to identify serious complications that have occurred in practice, but may not be reported in the literature (9,14).…”

Section: Utility Of Maudementioning

confidence: 99%

Investigating Complications Associated With Occipital Nerve Stimulation: A MAUDE Study

Doran

Ward

et al. 2018

Neuromodulation: Technology at the Neural Interface

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“…The database has been used to examine a range of devices, including robot-assisted surgical systems, endometrial ablation devices, catheters, bone-anchored hearing aids, cochlear implants, among others. 11-15 We searched for all medical device reports between January 1, 2008, and January 1, 2019. Only 3 companies have sinus balloons that have been approved by the Food and Drug Administration: Entellus, Acclarent, and Medtronic.…”

Section: Methodsmentioning

confidence: 99%

Adverse Events Associated with Balloon Sinuplasty: A MAUDE Database Analysis

Hur

Kim

et al. 2019

Otolaryngol.--head neck surg.

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Objective Balloon sinuplasty utilization has increased significantly since its introduction over a decade ago. However, the most common associated complications are still unknown. The objective of this study was to analyze adverse events related to balloon sinuplasty. Study Design Retrospective cross-sectional analysis. Setting Food and Drug Administration’s MAUDE database (Manufacturer and User Facility Device Experience; 2008-2018). Subjects and Methods The MAUDE database was searched for all reports on adverse events involving balloon sinuplasty devices from the 3 leading manufacturers: Acclarent, Entellus, and Medtronic. Reported events were reviewed and categorized. Results During the study period, there were 211 adverse events from 208 reports divided into the following categories: patient related (n = 102, 48.3%), device related (n = 101, 47.9%), and packaging related (n = 8, 3.8%). Four periprocedural deaths were reported but were not clearly associated with technical complications. The most common device-related complications were guide catheter malfunction (39.6%), balloon malfunction (38.6%), and imprecise navigation (17.8%). The most common patient-related complications were cerebrospinal fluid leak (36.3%), eye swelling (29.4%), and epistaxis (11.8%). A lateral canthotomy was performed in 30.0% of eye-swelling complications. Sixty percent of eye complications occurred during balloon dilation of the maxillary sinus. The years 2014 (n = 48) and 2012 (n = 32) had the highest number of adverse events reported as compared with all other years. Conclusion The most common adverse events associated with balloon sinuplasty include balloon malfunction, guide catheter malfunction, cerebrospinal fluid leak, and significant eye swelling. Health care providers should discuss these possible complications when consenting patients for balloon sinuplasty.

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“…In a recent study of the American College of Surgeons, it was found that only 12% of otolaryngologists had received claims against them in the past two years 1 , while a Danish study found an increasing trend in the number of otorhinolaryngology malpractice claims. In this specialty, complications are seldom severe, but are strongly surgery-related 2 , and, therefore, proper technical and non-technical skills and full compliance with guidelines and international standards are pivotal to avoid malpractice litigation 3 . "ENT Today" reported in October 2013 that, during the period 2007-2011, 53% of allegations against otolaryngologists were associated with "improper performance of surgery".…”

Section: Introductionmentioning

confidence: 99%

“…In this specialty, complications are seldom severe, but are strongly surgery-related 2 , and, therefore, proper technical and non-technical skills and full compliance with guidelines and international standards are pivotal to avoid malpractice litigation 3 . “ENT Today” reported in October 2013 that, during the period 2007-2011, 53% of allegations against otolaryngologists were associated with “improper performance of surgery”.…”

Section: Introductionmentioning

confidence: 99%

Are errors in otorhinolaryngology always a sign of medical malpractice? Review of the literature and new perspectives in the SARS-CoV-2 (COVID-19) era

Voultsos

Oliva

Grassi

et al. 2020

Acta Otorhinolaryngol Ital

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In medical practice, during certain procedures that usually are not regarded highly demanding, some skill-based errors, that might not be considered as medical malpractice, may occur. In fact, such errors can be caused by factors beyond the physician's control.A review of Greek case law regarding medical malpractice in otorhinolaryngology was performed to identify cases of lawsuits that concerned medical errors during routine procedures. The analysis of the cases showed that some medical errors may cause serious complications, even if deviation from the standard of medical care is minimal. Thus, in some cases it may be difficult to make a distinction between preventable and unpreventable complications. Certain medical errors from routine medical procedures might be considered unpreventable and, therefore, classified as almost no-fault errors. A brief commentary regarding opportunities to further improve the medical liability system after the SARS-CoV-2 emergency is also given.

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The Utility of the MAUDE Database for Osseointegrated Auditory Implants

Cited by 12 publications

References 14 publications

Investigating Complications Associated With Occipital Nerve Stimulation: A MAUDE Study

Investigating Complications Associated With Occipital Nerve Stimulation: A MAUDE Study

Adverse Events Associated with Balloon Sinuplasty: A MAUDE Database Analysis

Are errors in otorhinolaryngology always a sign of medical malpractice? Review of the literature and new perspectives in the SARS-CoV-2 (COVID-19) era

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