PathFile PTH0221ADEMORecalls & reported problems
Tulsa Dental Products LLC · PathFile 21mm Assortment Demo · Class 1
- 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 D716PTH0221ADEMO1), received between Nov 9, 2023 and Nov 9, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Abrasion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT PATHFILE 21MM ASSORTMENT FILE BENT DURING USE. REPORTEDLY, THERE WAS GINGIVAL BLEEDING. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Abrasion
MAUDE report 18100840 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.