POLAR CARE CUBE
Received Feb 3, 2023 · Event occurred Dec 2, 2022
Report 2028253-2023-00001 · MDR key 16294436
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
80 YR · Female
- Muscle/Tendon Damage
- Muscle/Tendon Damage
Narrative
Additional Manufacturer Narrative
NO PRODUCT HAS BEEN RETURNED FOR INVESTIGATION AND IT IS NOT EXPECTED THAT PRODUCT WILL BE AVAILABLE FOR EVALUATION. BASED ON THIS, IT WILL NOT BE POSSIBLE TO ESTABLISH IF THERE WAS A MALFUNCTION INVOLVED IN THIS ALLEGED INCIDENT. A REVIEW OF HISTORICAL COMPLAINTS IN THE LAST YEAR HAS REVEALED THAT THERE HAVE BEEN NO OTHER REPORTS OF ADVERSE EVENTS RELATED TO THIS ISSUE. NO MALFUNCTION INVOLVED WITH INCIDENT. IFU STATES: "YOU MAY DISCONNECT THE COLD THERAPY PAD FROM THE UNIT WITHOUT REMOVING THE PAD FROM THE AFFECTED AREA BY DEPRESSING THE SILVER TABS ON THE HOSE COUPLING AND GENTLY PULLING THE HOSES APART. THE BREG POLAR CARE COLD THERAPY PAD AND UNIT WILL SEAL ITSELF AND WILL NOT LEAK. NOTE: SOME DRIPPING DURING RELEASE IS NORMAL."
Description of Event or Problem
BREG RECEIVED MEDWATCH REPORT ALLEGING THE FOLLOWING, "POLAR CUBE WAS DISCONNECTED IN THE PATIENT'S ROOM AND THE COOLING PAD WAS WORN BY THE PATIENT UNDERNEATH THE BULKY DRESSING (STATUS POST TOTAL KNEE ARTHROPLASTY). THE ENDS OF THE TUBES ARE SUPPOSED TO SEAL WHEN DISCONNECTED. WHILE PATIENT WAS PARTICIPATING IN PHYSICAL THERAPY, A SMALL AMOUNT OF WATER HAD DRIPPED UNNOTICED ON THE STEPS. PATIENT SLIPPED ON THE WATER WHILE DESCENDING THE STAIRS CAUSING THE LEG TO FLEX FULLY AND INTERNALLY ROTATE. 5-6 DRIPS OF WATER WERE NOTED ON THE TOP STEPS WHILE PATIENT WAS SITTING AND RESTING ON THE STEPS. PATIENT REQUIRED SURGERY LATER TO REPAIR A TORN QUAD TENDON".