inforMED
InjuryIRT

THERMOPHORE

Received Nov 12, 2019

Report 1832415-2019-10825 · MDR key 9309600

Device

Generic name

Thermophore

Model number

155

Product problems

  • Improper or Incorrect Procedure or Method
  • Sparking
  • Electrical Shorting

Patient

Not reported

  • Burn, Thermal
  • Burn, Thermal

Narrative

Description of Event or Problem

CUSTOMER STATED, " CORD SHORTED AND BURNT HIS HIP". PRODUCT WAS NOT RETURNED. CUSTOMER CLAIMED A SPARK FORM THE CORD SHORTING OUT BURNT HIS HIP. THE CUSTOMER DID NOT PROVIDE A LOT CODE FOR THE PRODUCT. AN INVESTIGATION INTO SIMILAR FEEDBACKS FOR SPARKING FOUND THAT THE PRIMARY CAUSE WAS CUSTOMER MISUSE OF TWISTING/ WRAPPING THE CORD. THE IFU STATES, "LOOP CORD LOOSELY WHEN STORING. TIGHT WRAPPING MAY DAMAGE CORD AND INTERNAL PARTS."