Device adverse event reports (MAUDE)
Medical device reports of deaths, injuries and malfunctions sent to FDA by makers, facilities and the public. 26,849,547 records; openFDA updated it 2026-11-10. About this dataset
Newest records
- Failure to Osseointegrate2,543,838
- Adverse Event Without Identified Device or Use Problem1,969,944
- Break1,233,929
- Wireless Communication Problem1,184,440
- Device Displays Incorrect Message997,011
- Loss of Osseointegration934,497
- Crack901,510
- Incorrect, Inadequate or Imprecise Result or Readings818,719
- Malfunction16,796,984
- Injury9,656,791
- Death232,397
- Other105,886
- 56,494
- No answer provided995
- da Vinci Xi · SURGEON SIDE CONSOLE, RECONDITIONED
INTUITIVE SURGICAL, INC · Unintended System Motion
- FreeStyle Libre 3 Plus · Continuous Glucose Monitoring System
Abbott Diabetes Care Inc · Device Alarm System
- FreeStyle Libre 2 Plus · Flash Glucose Monitoring System
Abbott Diabetes Care Inc · High Readings
- LifeVest WCD 5100 System · Wearable Cardioverter Defibrillator
ZOLL Manufacturing Corporation · Patient Device Interaction Problem
- CADD-Solis VIP Ambulatory Infusion Pump · Pump, Infusion
ICU Medical, Inc. · Detachment of Device or Device Component
- Omnipod 5 Automated Insulin Delivery System · Automated Insulin Delivery System
Insulet Corporation · Obstruction of Flow, Insufficient Device Problem Information
- EVIS EXERA III COLONOVIDEOSCOPE · COLONOVIDEOSCOPE
AIZU OLYMPUS CO., LTD. · Poor Quality Image
- FOGARTY SAFEJAW · CLAMP, VASCULAR
Edwards Lifesciences PR · Contamination
- Gallant HF · Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Abbott Medical (CRM-Sylmar) · Over-Sensing
- t:slim X2 Insulin Pump with Control-IQ+ Technology · Alternate Controller Enabled Insulin Infusion Pump
Tandem Diabetes Care · Obstruction of Flow
- OsseoSpeed TX 4.5 - 9 mm · implant, endosseous, root-form
Dentsply Implants Manufacturing GmbH · Failure to Osseointegrate
- t:slim X2 Insulin Pump with Control-IQ+ Technology · Alternate Controller Enabled Insulin Infusion Pump
Tandem Diabetes Care · Obstruction of Flow
- Aurora EV-ICD¿ MRI SureScan¿ · IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Medtronic Europe Sarl · Signal Artifact/Noise, Electromagnetic Interference +1
- Tandem Mobi Insulin Pump with Control-IQ+ Technology · Alternate Controller Enabled Insulin Infusion Pump
Tandem Diabetes Care · Obstruction of Flow
- MiniMed 780G OUS System BLE Connect 3.0 mmol/L · AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL
Medtronic Puerto Rico Operations Co. · Key or Button Unresponsive/not Working
- t:slim X2 Insulin Pump with Control-IQ+ Technology · Alternate Controller Enabled Insulin Infusion Pump
Tandem Diabetes Care · Obstruction of Flow
- Dexcom G7 Continuous Glucose Monitoring System · Continuous Glucose Monitor
Dexcom, Inc. · Wireless Communication Problem
- t:slim X2 Insulin Pump with Control-IQ+ Technology · Alternate Controller Enabled Insulin Infusion Pump
Tandem Diabetes Care · Obstruction of Flow
- t:slim X2 Insulin Pump with Control-IQ+ Technology · Alternate Controller Enabled Insulin Infusion Pump
Tandem Diabetes Care · Obstruction of Flow
- Dexcom G7 Continuous Glucose Monitoring System · Continuous Glucose Monitor
Dexcom, Inc. · Wireless Communication Problem
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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.
