HU-FRIEDY
Received Apr 9, 2026 · Event occurred Mar 11, 2026
Report 1416605-2026-00003 · MDR key 24834694
Device
Generic name
#11/12 Odu De Explorer, #7 Handle
Manufacturer
Hu-friedy Mfg. Co., LlcModel number
EXD11/127Catalog number
EXD11/127
Lot number
0624
Product problems
- Break
Patient
NA · Unknown
- Foreign Body In Patient
Narrative
Description of Event or Problem
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.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE EVIDENCE, THE DISLODGEMENT OF THE WORKING END IS MOST LIKELY ATTRIBUTABLE TO EXCESSIVE EXTERNAL MECHANICAL FORCES APPLIED DURING USE, RATHER THAN AN INHERENT MATERIAL, DESIGN, OR MANUFACTURING DEFECT. NO RELATED DEFECTS IDENTIFIED IN INSPECTION HISTORY FOR THIS LOT LOW COMPLAINT AND RETURN RATES.