inforMED
InjuryLHC

INTRATEMP/THERMABASIN

Received Oct 19, 2007

Report 3005853119-2007-00001 · MDR key 931035

Device

Generic name

Fluid Warmer - Intra Temp/thermabasin

Model number

ITK-6000

Catalog number

ITK-6000

Lot number

76104

Product problems

  • Use of Device Problem

Patient

YR

  • Burn, Thermal

Narrative

Description of Event or Problem

WE RECEIVED A REPORT OF A NEWBORN HAVING SUFFERED A BURN FROM BEING PLACED INTO OUR DEVICE (IN AN OFF-LABEL USE/APPLICATION).

Additional Manufacturer Narrative

OFF-LABEL USAGE BY USER FACILITY (NEWBORN BATHING). WRITTEN RECOMMENDATION TO BE SENT TO USER FACILITY AGAINST THIS APPLICATION. REPEATED PHONE CALLS AND VOICEMAIL MESSAGES HAVE ELICITED NO RESPONSE. LABELING REVIEW INITIATED.

Remedial action

  • Other