CLEARTRACE 1700-005Recalls & reported problems
Conmed Corporation · CLEARTRACE ADULT ECG ELECTRODE · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405004240), received between Mar 18, 2024 and Mar 18, 2024 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blister1
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 1700-005, CLEARTRACE;5;TP,ADGEL, WAS USED FOR UNKNOWN REASON ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿PATIENT HAD AN ALLERGIC REACTION, FULL BLISTER THE CIRCUMFERENCE OF THE ELECTRODE. BLISTERS ENDED UP OOZING AFTER SHE TOOK THE ELECTRODES OFF. THEY DO NOT BELIEVE THAT SHE MADE IT 6 HOURS WITH THEM ON, BUT ARE UNSURE.". THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. THERE HAS NOT BEEN ANY ALLEGATION OF MALFUNCTION OF THE DEVICE TO DATE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF ALLERGIC REACTION/BLISTERING TO THE PATIENT.
Patient problems: Blister; Hypersensitivity/Allergic reaction
MAUDE report 18920404 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.