inforMED
InjuryEMN

HU-FRIEDY

Received Dec 31, 2025 · Event occurred Dec 4, 2025

Report 1416605-2025-00009 · MDR key 23933703

Device

Generic name

Scaler

Model number

SCNEVI4XE2

Catalog number

SCNEVI4XE2

Product problems

  • Sharp Edges
  • Sharp Edges

Patient

NA · Female

  • Laceration(s)
  • Laceration(s)

Narrative

Additional Manufacturer Narrative

DEVICE WAS NOT RETURNED. LOT NUMBER WAS NOT PROVIDED.

Description of Event or Problem

USER REPORTED THAT THERE WAS A PIECE OF METAL STICKING OUT OF THE SCALER HANDLE. METAL POKED THROUGH USER'S GLOVES.