inforMED
OtherIME

CAROLON 6X10 GEL 24/CS

Received Oct 12, 2005 · Event occurred Sep 6, 2005

Report 1423507-2005-00121 · MDR key 640324

Device

Generic name

Reuseable Hot Gel Pack

Manufacturer

Cardinal Health

Model number

08062

Catalog number

08062

Lot number

UNK

Product problems

  • Heat
  • Leak/Splash

Patient

UNKNOWN

  • Burn(s)
  • Treatment with medication(s)

Narrative

Description of Event or Problem

END USER REPORTED TO THE CUSTOMER, CAROLON, THAT HE HAD HEATED THE GEL PACK AND PLACED IN ON HIS RIGHT CALF. HE SAID HE ELEVATED HIS FOOT AND FELT HIS CALF GETTING HOT, AND THEN SAW THAT THE GEL HAD LEAKED AND HE SAID IT HAD BURNED HIS CALF. HE PUT OINTMENT AND A PAD ON THE BUM, AND SAID HE IS NOT SEEKING MEDICAL HELP.