inforMED
InjuryIMG

CHATTANOOGA

Received Mar 5, 2025 · Event occurred Feb 14, 2025

Report 9616086-2025-00021 · MDR key 21532030

Device

Generic name

Intelect Legend Xt Combous Std

Manufacturer

Djo Llc

Catalog number

2760

Lot number

T17605

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Patient Device Interaction Problem
  • Adverse Event Without Identified Device or Use Problem
  • Patient Device Interaction Problem

Patient

NA · Unknown

  • Burn(s)
  • Burn(s)

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE UNIT HAS BURNED PATIENT DURING INTERFERENTIAL TREATMENT. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THE ROOD CAUSE COULD NOT BE ESTABLISHED. IF MORE INFORMATION BECOMES AVAILABLE ADDITIONAL REPORTING WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT.

Description of Event or Problem

IT WAS REPORTED THAT THE UNIT HAS BURNED PATIENT DURING INTERFERENTIAL TREATMENT.