DeRoyal 88-000M12CRecalls & reported problems
Deroyal Industries, Inc. · Coated Needle Electrode · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756135993), received between Aug 8, 2024 and Aug 8, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Compatibility Problem” (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
- Compatibility Problem1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2024Compatibility Problem; Compatibility Problem
A NEW CUSTOMER COMPLAIN ABOUT OUR ELECTRODE. WE WENT TO SPEAK WITH THE SURGEON AND HE TOLD US WHEN THE BLOOD ENTERS THROUGH THE HOLE WHERE THE ELECTRODE IS INSERTED IN THE HANDLE AND WHEN THE BLOOD OR LIQUID COMES OUT AGAIN IT BURNS THE PATIENT.
Patient problems: Burn(s)
MAUDE report 19941301 ↗
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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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