inforMED
InjuryIME

CHATTANOOGA

Received May 20, 2026 · Event occurred Apr 24, 2026

Report 9616086-2026-00021 · MDR key 25236915

Device

Generic name

Compress Cold/hot 5x10 Case/24

Manufacturer

Djo Llc

Model number

4020

Product problems

  • Temperature Problem

Patient

NA · Unknown

  • Burn(s)

Narrative

Description of Event or Problem

THE CUSTOMER REPORTED THAT A CHILD WAS BURNED AND HAD TO BE TAKEN TO THE EMERGENCY ROOM DUE TO THE FLEXIPAC LEAKING.

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT A CHILD WAS BURNED AND HAD TO BE TAKEN TO THE EMERGENCY ROOM DUE TO THE FLEXIPAC LEAKING. NO FURTHER INFORMATION WAS RECEIVED. DEVICE NOT RETURNED FOR EVALUATION. THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF NEW INFORMATION BECOMES AVAILABLE.