MEDLINE ES0014AMRecalls & reported problems
Medline Industries, Inc. · PTFE CTD BLADE EXT INS 4' · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196297184), received between Jan 4, 2021 and Jan 4, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Missing” (2 reports).
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.
Most reported problems
Device problems
- Component Missing2
- Device Damaged Prior to Use1
Patient problems
- Superficial (First Degree) Burn2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 4, 2021Device Damaged Prior to Use; Component Missing
IT WAS REPORTED THE PROTECTED TIP (ON THE BLUE SILK BLADE ELECTRODE) CAME DEFECTIVE OUT OF THE PACKAGE WITH INSULATION MISSING AND BURNED A PATIENT.
Patient problems: Superficial (First Degree) Burn
MAUDE report 11108604 ↗MalfunctionJan 4, 2021Component Missing
IT WAS REPORTED THE PROTECTED TIP (ON THE BLUE SILK BLADE ELECTRODE) CAME DEFECTIVE OUT OF THE PACKAGE WITH INSULATION MISSING AND BURNED A PATIENT.
Patient problems: Superficial (First Degree) Burn
MAUDE report 11108295 ↗
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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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