Devon 31145777Recalls & reported problems
Cardinal Health, Inc. · Skin Marker,Regular Tip with Ruler and Labels · Class 1
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 10884527007509), received between Sep 18, 2017 and Sep 18, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2017Leak/Splash; Leak/Splash
THE CUSTOMER REPORTS THAT THE OPEN MARKER CAP AND THE TIP OF THE PEN WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 6874836 ↗
Other MARKER, SKIN devices
- Devon 31145892Cardinal Health, Inc. · MARKER, SKIN1 report
- Key Surgical Skin Markers SM-300Key Surgical, Inc. · Marker, Skin1 report
- Devon 31146020Cardinal 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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