InjuryIRT
THERMOPHORE
Received Nov 12, 2019
Report 1832415-2019-10825 · MDR key 9309600
Device
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."