FDA Adverse Event
Injury
Summary report: N
#23/UNC12 EXPRO #7 HANDLE
MDR report key: 24702145
·
Received March 26, 2026
Report
- Report Number
- 1416605-2026-00004
- Event Type
- Injury
- Date Received
- March 26, 2026
- Date of Event
- March 5, 2026
- Report Date
- March 26, 2026
- Manufacturer
- HU-FRIEDY MANUFACTURING CO., LLC
- Product Code
- EIX
- UDI-DI
- 10889950034931
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE SUBJECT OF THE REPORTED EVENT WAS RETURNED TO HU-FRIEDY FOR EVALUATION. THE PROBE TIP WAS LIKELY SUBJECTED TO EXCESSIVE FORCE DURING USE, LEADING TO THE BREAKAGE OF THE POINT. THIS INDICATES A USE-RELATED FAILURE MECHANISM. THE DEVICE HISTORY RECORD FOR THE SUBJECT LOT WAS REVIEWED. RETURN RATES AND COMPLAINT RATES ARE LOW, NO FURTHER ACTION WILL BE TAKEN.
Description of Event or Problem · 0
THE USER FACILITY REPORTED THAT DURING A DENTAL PROCEDURE THE TIP OF THE PROBE BROKE IN PATIENT'S MOUTH AND THE PATIENT MIGHT HAVE SWALLOWED IT. A RADIOGRAPH WAS TAKEN TO LOCATE THE TIP AND THEY FOUND NO EVIDENCE OF THE TIP. PATIENT DECLINED ANY FURTHER MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28739 | #23/UNC12 EXPRO #7 HANDLE | EXPRO PROBE | EIX | HU-FRIEDY MANUFACTURING CO., LLC | XP23/NC127 | 0425 | 10889950034931 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |