HU-FRIEDY EXD11/127Recalls & reported problems
Hu-Friedy Mfg. CO., LLC · #11/12 ODU DE Explorer, #7 Handle · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889950010829), received between Apr 9, 2026 and Apr 9, 2026 — classified as 1 injury.
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
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 9, 2026Break
INSTRUCTOR (B)(6) CALLED IN AND REPORTED DURING TREATMENT, A FACULTY MEMBER WAS USING AN 11/12 EXPLORER AND THE ENTIRE WORKING END DISLODGED FROM THE HANDLE DURING EXPLORING IN THE PATIENTS MOUTH. PATIENT SWALLOWED THE WORKING END. PATIENT WAS INSTRUCTED TO GO TO THE LOCAL EMERGENCY ROOM AT THE HOSPITAL.
Patient problems: Foreign Body In Patient
MAUDE report 24834694 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.