2023
Adverse Events Associated With Tracheostomy: A MAUDE Database Analysis
Narwani V, Dacey S, Lerner M. Adverse Events Associated With Tracheostomy: A MAUDE Database Analysis. Otolaryngology 2023, 170: 391-395. PMID: 37622490, DOI: 10.1002/ohn.501.Peer-Reviewed Original ResearchAdverse eventsPercutaneous tracheostomyMAUDE databasePatient-related adverse eventsRetrospective cross-sectional studyDevice-related adverse eventsDevice malfunctionMAUDE Database AnalysisTracheostomy tube obstructionPatient-related factorsRare adverse eventsUser Facility Device Experience (MAUDE) databaseCross-sectional studyBalloon malfunctionDevice-related failuresTracheostomy complicationsTube obstructionOpen tracheostomyCase reportDevice complicationsCuff deflationTracheostomyLine malfunctionPatient injuryFDA MAUDE databaseComparing nationally reported adverse events associated with coblation vs. PlasmaBlade for tonsillectomy
Shah R, Shah H, Rohrbaugh T, Reeder A, Kohli N, Maurrasse S. Comparing nationally reported adverse events associated with coblation vs. PlasmaBlade for tonsillectomy. American Journal Of Otolaryngology 2023, 44: 103894. PMID: 37178539, DOI: 10.1016/j.amjoto.2023.103894.Peer-Reviewed Original ResearchConceptsAdverse eventsBurn injuryDevice malfunctionPatient-related adverse eventsRetrospective cross-sectional studyCoblation deviceCommon device malfunctionsUser Facility Device Experience (MAUDE) databaseCross-sectional studyIntraoperative tipsPreoperative discussionPhysician comfortRadiofrequency ablationPEAK PlasmaBladeTonsillectomyUS FoodCoblationPatientsMAUDE databasePlasmaBladeInjuryAdenoidectomyIntraoperative fireExperience databaseReportAdverse Events Associated With Bioabsorbable Nasal Implants: A MAUDE Database Analysis
Wilkins S, Sheth A, Kayastha D, Abdou H, Salehi P, Citardi M, Manes R. Adverse Events Associated With Bioabsorbable Nasal Implants: A MAUDE Database Analysis. Otolaryngology 2023, 168: 1253-1257. PMID: 36939542, DOI: 10.1002/ohn.227.Peer-Reviewed Original ResearchConceptsAdverse eventsNasal implantsPotential long-term complicationsMAUDE Database AnalysisLong-term complicationsPain/discomfortUser Facility Device Experience (MAUDE) databaseNasal valve collapseSteroid injectionTreatment sequelaeStandardized reporting templateCommon symptomsAdverse reactionsPathologic analysisValve collapseImplant protrusionAdjacent tissuesMAUDE databaseDevice reportsReporting templateDatabase analysisBioabsorbable implantsComplicationsImplantsExperience database
2022
Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra
Kadakia KT, Beckman AL, Ross JS, Krumholz HM. Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra. JAMA Internal Medicine 2022, 182: 59-65. PMID: 34842892, DOI: 10.1001/jamainternmed.2021.6626.Commentaries, Editorials and LettersConceptsReperfusion catheterClinical evidenceClass IPenumbra reperfusion catheterSingle-arm trialUser Facility Device Experience (MAUDE) databaseAdverse event reportsPostmarket surveillanceHealth policy makersMedical device reportsPenumbra deviceClinical evaluationPatient deathDevice safetyMedicine recommendationsAnimal dataCatheterFDA databaseFDA medical device regulationsClinical literatureSmall sample sizeDevice reportsEvent reportsPublic healthExperience database
2021
Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data
Aggarwal N, Chow R. Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data. Anesthesia And Pain Medicine 2021, 16: 177-183. PMID: 33866770, PMCID: PMC8107255, DOI: 10.17085/apm.20093.Peer-Reviewed Original ResearchAdverse eventsInterspinous spacerReal-world adverse eventsProgressive neurogenic claudicationLumbar decompression surgeryLumbar spinal stenosisUser Facility Device Experience (MAUDE) databaseInterspinous process spacerInterspinous spacer devicesInterspinous process deviceConservative therapyNeurogenic claudicationDecompression surgerySpinal stenosisPain/Spacer deviceUS FoodDrug AdministrationDisproportionality analysisFurther studiesExperience databaseClaudicationStenosisSurgeryTherapy
2020
A Manufacturer and User Facility Device Experience Analysis of Upper Aerodigestive Endoscopy Contamination: Is Flexible Laryngoscopy Different?
Jiang R, Kasle DA, Alzahrani F, Kohli N, Lerner MZ. A Manufacturer and User Facility Device Experience Analysis of Upper Aerodigestive Endoscopy Contamination: Is Flexible Laryngoscopy Different? The Laryngoscope 2020, 131: 598-605. PMID: 32558941, DOI: 10.1002/lary.28826.Peer-Reviewed Original Research
2001
Unexpected ICD Pulse Generator Failure Due to Electronic Circuit Damage Caused by Electrical Overstress
HAUSER R, HAYES D, ALMQUIST A, EPSTEIN A, PARSONNET V, TYERS G, VLAY S, SCHOENFELD M. Unexpected ICD Pulse Generator Failure Due to Electronic Circuit Damage Caused by Electrical Overstress. Pacing And Clinical Electrophysiology 2001, 24: 1046-1054. PMID: 11475818, DOI: 10.1046/j.1460-9592.2001.01046.x.Peer-Reviewed Original ResearchConceptsAdverse event reportsPulse generator failuresSerious adverse eventsUser Facility Device Experience (MAUDE) databaseMulticenter registryAdverse eventsRoutine followICD functionLead failureExternal defibrillationFDA ManufacturerEvent reportsRegistryIncidenceICDLoss of telemetryExperience databaseLifesaving devicesPacemakerFailureSigns of failureElectrosurgical device
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