inforMED
MalfunctionIRT

THERMOPHORE

Received Feb 12, 2020

Report 1832415-2020-11071 · MDR key 9702515

Device

Generic name

Thermophore

Model number

156

Lot number

00156310181

Product problems

  • Break
  • Thermal Decomposition of Device
  • Material Twisted/Bent

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

CUSTOMER STATED "THE LIGHT COMES ON BUT THERE IS NO HEAT." CUSTOMER DID NOT CLAIM INJURY. PRODUCT WAS RETURNED. THE INVESTIGATOR OBSERVED A BURN MARK ON THE INSIDE OF THE UNIT BY THE BUTTERFLY. THE INVESTIGATOR DETERMINED TWISTING OF THE WIRES CONNECTING THE CORD TO THE PAD CAUSED A BREAK IN THE CORD, WHICH LEAD TO THE BURN MARK. THIS IS A MANUFACTURES DEFECT. AFTER FURTHER INVESTIGATION, NO ADDITIONAL PRODUCT WAS IMPACTED AND NO ADDITIONAL ACTIONS WERE REQUIRED.