OtherIME
CAROLON 6X10 GEL 24/CS
Received Oct 12, 2005 · Event occurred Jul 6, 2005
Report 1423507-2005-00120 · MDR key 640230
Device
Generic name
Reuseable Hot Gel Pack
Manufacturer
Cardinal HealthModel number
08062Catalog number
08062
Lot number
UNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Burn(s)
- Therapy/non-surgical treatment, additional
- Hospitalization required
Narrative
Description of Event or Problem
THE END USER CUSTOMER REPORTED TO THE CUSTOMER THAT HE HEATED THE GEL PACK AS INSTRUCTED. HE SAID HE PUT THE PACK ON HIS LEFT ANKLE AND THERE WAS A DRASTIC BURN. HE WENT TO A CLINIC A FEW DAYS LATER, AND THEN HE WENT LATER TO THE EMERGENCY ROOM. HE SAID HE IS NOW BEING TREATED AT A BURN AND TRAUMA CENTER FOR 2ND AND 3RD DEGREE BURNS. HE SAID HE IS CURRENTLY USING SALVES AND WRAPS ON THE BURN.