InjuryIRT
DMI
Received Oct 17, 2024 · Event occurred Sep 24, 2024
Report 1000143485-2024-25105 · MDR key 20471378
Device
Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
34 YR · Female
- Pain
- Fluid Discharge
- Partial thickness (Second Degree) Burn
- Blister
- Pain
- Fluid Discharge
- Partial thickness (Second Degree) Burn
- Blister
Narrative
Additional Manufacturer Narrative
REQUEST FOR UNIT TO BE RETURNED. DEVICE WAS NOT AVAILABLE FOR INSPECTION AT THIS TIME. UNIT IS OVER 5 YEARS OLD AND CONTAINS INSTRUCTIONS NOT TO USE WHILE SLEEPING.
Description of Event or Problem
DUE TO JOINT PAINT, PATIENT WENT TO BED WITH HEATING PAD ON ANKLE AND WORK UP 4 HOURS LATER TO PAIN. THE NEXT DAY PATIENT HAD SEVERE LEG PAIN AND THE SKIN WAS PEELING/BLISTERING. PATIENT WENT TO DOCTOR AND WAS TOLD PATIENT HAD 2ND DEGREE BURN.