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
- Dexcom G7 15 Day Continuous Glucose Monitoring System · Continuous Glucose Monitor
Dexcom, Inc. · Wireless Communication Problem
- 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 · Incorrect Measurement
- Dexcom G7 Continuous Glucose Monitoring System · Continuous Glucose Monitor
Dexcom, Inc. · Wireless Communication Problem
- Dexcom G7 Continuous Glucose Monitoring System · Continuous Glucose Monitor
Dexcom, Inc. · Wireless Communication Problem
- Dexcom G7 15 Day Continuous Glucose Monitoring System · Continuous Glucose Monitor
Dexcom, Inc. · Wireless Communication Problem
- Medtronic Transcatheter Valve · AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
Medtronic Mexico S. De R.L. De CV · Gradient Increase, Patient Device Interaction Problem
- TENDRIL SDX LEAD · Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
Abbott Medical (CRM-Sylmar) · Signal Artifact/Noise
- Pump 1886 780G OUS BLE Pump mg/dL · AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL
Medtronic Puerto Rico Operations Co. · Circuit Failure
- LigaSure · ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
Covidien · Retraction Problem, Protective Measures Problem
- Single Use 3-Lumen Sphincterotome V · SINGLE USE 2-LUMEN SPHINCTEROTOME
Olympus Vietnam Co. Ltd. · Material Twisted/Bent
- MiniMed 780G OUS System BLE Connect 3.0 mmol/L · AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL
Medtronic Puerto Rico Operations Co. · Circuit Failure
- Coolsculpting System · Dermal cooling pack/vacuum/massager
Allergan Pleasanton · Adverse Event Without Identified Device or Use Problem
- VALLEYLAB · ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
Covidien · Self-Activation or Keying, Device Displays Incorrect Message +1
- SMARTABLATE · Cardiac Ablation Percutaneous Catheter
Biosense Webster Inc · Contamination /Decontamination Problem
- Medline · METER, GLUCOSE, HARMONY,PROF.USE ONLY
Medline Industries, LP · Electrical /Electronic Property Problem
- Spectrum IQ · Pump, infusion
BAXTER HEALTHCARE CORPORATION · False Alarm
- CLEARLINK · Set, administration, intravascular
BAXTER HEALTHCARE CORPORATION · Nonstandard Device
- DJO SURGICAL · EMPOWR Acetabular System, Liner, Neutral, HXe+, 40G
Encore Medical L.P · Adverse Event Without Identified Device or Use Problem
- DJO SURGICAL · INSERT, REVISION EXPRT, SZ C X 14.5MM, E-PLUS
Encore Medical L.P · Unstable
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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.