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FDA Adverse Event Death Reports

View 10000 FDA Adverse Event Death Reports on BEUDAMED, the Better Database on Medical Devices. These entries compile device-related fatality reports submitted to U.S. regulatory sources and manufacturers, highlighting cases where a medical device was associated with a death. The dataset covers implants, life-supporting systems, diagnostics, and other device categories to help identify safety trends.

Use these death reports to monitor safety signals, support post-market surveillance, and inform clinical and regulatory decision-making. Each report includes device identifiers, event descriptions, timelines, and reporter information, but individual reports do not by themselves establish causality. Users should combine this data with clinical review and manufacturer investigations for accurate risk assessment.

CUSTOM PERFUSION SYSTEM

FDA Adverse Event
Death ·MEDTRONIC·Product code KFM·December 19, 2016

MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

FDA Adverse Event
Death ·AV-TEMECULA-CT·Product code NKM·October 6, 2016

AEX GENERATOR

FDA Adverse Event
Death ·MEDTRONIC ADVANCED ENERGY, LLC·Product code GEI·October 7, 2016

DAC 057 125CM

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code DQY·October 21, 2016

ENDURANT II ILIAC STENT GRAFT

FDA Adverse Event
Death ·MEDTRONIC IRELAND·Product code MIH·October 28, 2016

IPERIA 7 DR-T DF4 PROMRI

FDA Adverse Event
Death ·BIOTRONIK SE & CO. KG·Product code MRM·December 1, 2016

OPTISENSE

FDA Adverse Event
Death ·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code NVN·November 13, 2016

PD SERIES MAESTRO FIXED DURAGUARD

FDA Adverse Event
Death ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·November 18, 2016

HI-TORQUE WHISPER MS GUIDE WIRE

FDA Adverse Event
Death ·AV-TEMECULA-CT·Product code DQX·November 4, 2016

HEARTSTART FRX

FDA Adverse Event
Death ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 10, 2016