MalfunctionILO
THERMAZONE THERMAL THERAPY
Received Oct 27, 2025 · Event occurred Oct 17, 2025
Report MW5177985 · MDR key 23390691
Device
Generic name
Pack, Hot Or Cold, Water Circulating
Manufacturer
Innovative Medical EquipmentModel number
003-28Lot number
101892
Product problems
- Patient-Device Incompatibility
Patient
NA · Unknown
- Skin Discoloration
- Skin Discoloration
Narrative
Description of Event or Problem
NURSE NOTIFIED BY THERAPY STAFF, PATIENT HAD RED MARKS IN THE SHAPE OF A THERMAZONE PAD ON HIS BACK. WHEN ASSESSED, THE PATIENT HAD BLANCHABLE REDNESS ON HIS RIGHT BACK, GETTING LIGHTER TOWARD LEFT SIDE OF HIS BACK. THE PAD HAD BEEN REMOVED BY THE PATIENT AT 21:00 THE EVENING BEFORE. PATIENT DENIES PAIN, ITCHING, OR BURNING AT SITE OF REDNESS.