Device adverse event reports (MAUDE)
Medical device reports of deaths, injuries and malfunctions sent to FDA by makers, facilities and the public. 26,136,889 records; openFDA updated it 2026-10-05. About this dataset
Newest records
- Failure to Osseointegrate2,468,739
- Adverse Event Without Identified Device or Use Problem1,932,990
- Break1,217,351
- Wireless Communication Problem1,153,080
- Device Displays Incorrect Message996,496
- Loss of Osseointegration904,059
- Crack899,201
- Insufficient Device Problem Information702,276
- Malfunction16,294,894
- Injury9,450,642
- Death230,699
- Other103,170
- 56,489
- No answer provided995
- Vanta · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
MEDTRONIC PUERTO RICO OPERATIONS CO. · High impedance
- STRATAFIX Symmetric PDS Plus · Suture, surgical, absorbable, polydioxanone
Ethicon Inc. · Adverse Event Without Identified Device or Use Problem
- FreeStyle Libre 2 · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Abbott Diabetes Care Inc · Incorrect, Inadequate or Imprecise Result or Readings
- MiniMed 780G US System BLE Connect 3.0 mg/dL · Alternate Controller Enabled Insulin Infusion Pump
Medtronic Puerto Rico Operations Co. · Power Problem
- Dexcom G7 Continuous Glucose Monitoring System · Continuous Glucose Monitor
Dexcom, Inc. · Wireless Communication Problem
- HeartStart MRx monitor/defib · Defibrillator
Philips North America LLC · Key or Button Unresponsive/not Working
- HeartStart XL+ Defibrillator/Monitor · Defibrillator
Philips North America LLC · Failure of Device to Self-Test
- Heart Start XL · Defibrillator
Philips North America LLC · Failure of Device to Self-Test
- RayOne EMV Toric · RayOne EMV Toric
Rayner Intraocular Lenses Limited · Difficult to Fold, Unfold or Collapse, Failure to Eject
- EMBLEM MRI S-ICD · Implantable Device
BOSTON SCIENTIFIC CORPORATION · Signal Artifact/Noise, Over-Sensing +2
- EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE · BRONCHOFIBERVIDEOSCOPE
SHIRAKAWA OLYMPUS CO., LTD. · Detachment of Device or Device Component
- FreeStyle Libre 2 Plus · Flash Glucose Monitoring System
Abbott Diabetes Care Inc · Device Alarm System
- FreeStyle Libre 3 Plus · Continuous Glucose Monitoring System
Abbott Diabetes Care Inc · Device Alarm System
- FreeStyle Libre 3 · Continuous Glucose Monitoring System
Abbott Diabetes Care Ltd · Device Alarm System
- FreeStyle Libre 2 · Flash Glucose Monitoring System
Abbott Diabetes Care Inc · Device Alarm System
- BRONCHOVIDEOSCOPE · BRONCHOVIDEOSCOPE
AIZU OLYMPUS CO., LTD. · Detachment of Device or Device Component
- FreeStyle Libre 2 Plus · Flash Glucose Monitoring System
Abbott Diabetes Care Inc · Device Alarm System
- 4K CAMERA HEAD · AUTOCLAVABLE CAMERA HEAD
SHIRAKAWA OLYMPUS CO., LTD. · Gas/Air Leak
- Proclaim¿ 5 Elite Implantable Pulse Generator · SCS IPG
Abbott Medical · Adverse Event Without Identified Device or Use Problem
- FreeStyle Libre 2 · Flash Glucose Monitoring System
Abbott Diabetes Care Inc · Device Alarm System
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How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.