Key Surgical Skin Markers SM-300Recalls & reported problems
Key Surgical, Inc. · Skin Markers, Sterile, Dual tip (1 mm and 0.5 mm) with Ruler and 6 labels · Class 1
Data updated Oct 18, 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 00849771030485), received between Aug 23, 2023 and Aug 23, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device 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 18, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2023Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AT THE BEGINNING OF A PATIENT PROCEDURE, IT WAS NOTED THAT THE INK FROM THEIR SKIN MARKER THAT WAS USED TO DRAW ON THE PATIENT PRIOR TO THE PROCEDURE HAD RUBBED OFF OF THE PATIENT'S SKIN. THE MARKINGS HAD TO BE REDRAWN RESULTING IN A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17602759 ↗
Other Marker, Skin devices
- Devon 31145777Cardinal Health, Inc. · MARKER, SKIN1 report
- Devon 31146020Cardinal Health, Inc. · MARKER, SKIN1 report
- Devon 31145892Cardinal Health, Inc. · MARKER, SKIN1 report
- Devon 31145827Cardinal Health, Inc. · MARKER, SKIN1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page