Megadyne 0850CRecalls & reported problems
Megadyne Medical Products, Inc. · Patient Return Electrode, Single-Use, Non Contact Quality Monitoring, Adult, With 9 ft (2.7 m) Cord, For Patients Weighing Over 33lbs. (15kg) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10614559102749), received between Apr 26, 2021 and Mar 5, 2025 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Activation” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Appropriate Device Problem Term/Code Not Available1
- Difficult or Delayed Activation1
Patient problems
- Partial thickness (Second Degree) Burn4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blister1
- No Clinical Signs, Symptoms or Conditions1
- Scar Tissue1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A CADAVER LAB THE BOVIE WERE AROUND 30 CUT 30 COAG. THE SURGEON GOT BURNED THROUGH THEIR GLOVES.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 21528875 ↗MalfunctionMar 5, 2025Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A CADAVER LAB THE BOVIE WERE AROUND 30 CUT 30 COAG. THE SURGEON GOT BURNED THROUGH THEIR GLOVES.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Partial thickness (Second Degree) Burn
MAUDE report 21528782 ↗MalfunctionMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A CADAVER LAB THE BOVIE WERE AROUND 30 CUT 30 COAG. THE SURGEON GOT BURNED THROUGH THEIR GLOVES.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 21528638 ↗InjuryMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING AN UNKNOWN PROCEDURE, THE PATIENT GOT BURNT WHILE USING THE ELECTRODE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN.
Patient problems: Blister; Partial thickness (Second Degree) Burn; Scar Tissue
MAUDE report 11764090 ↗MalfunctionApr 26, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT HAD A RED MARK WHERE THE GROUNDING PAD WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11725446 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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