inforMED
MalfunctionIRT

THERMOPHORE

Received Feb 5, 2020

Report 1832415-2020-11042 · MDR key 9673696

Device

Generic name

Thermophore

Model number

155

Lot number

00155016195

Product problems

  • Device Emits Odor
  • Improper or Incorrect Procedure or Method
  • Sparking

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, "SMELLED AN ELECTRICAL BURNING ODOR. SHE LOOKED DOWN AND SAW A SPARK COME FROM THE CORD. SHE PUTS THE PAD ON THE WEDGE AND LAYS BACK ON IT. SOMETIMES SHE LAYS FLAT ON THE FLOOR ON THE PAD. SOMETIMES SHE WRAPS THE PAD AROUND HER LOWER LEG" CUSTOMER DID NOT CLAIM INJURY. PRODUCT WAS RETURNED. THE INVESTIGATOR OBSERVED A BURN MARK ON THE CORD AT THE BUTTERFLY. THE INVESTIGATOR DETERMINED THE BURN WAS CAUSED BY THE INSULATION OF THE WIRES BEING WORE DOWN, DUE TO EXCESSIVE FLEXING OF THE CORD. THE INVESTIGATOR OBSERVED EVIDENCE TO CORROBORATE THE USERS STATEMENT OF MISUSE OF LAYING ON AND WRAPPING THE PAD WHILE IN USE. THE IFU STATES, NEVER WRAP, HOLD, OR LOOP THE CORD IN ANY POSITION WHICH SHARPLY BENDS IT. IFU STATES, "DO NOT SIT ON, LIE ON, OR CRUSH PAD. AVOID SHARP FOLDS".