BREG POLAR CARE REUSABLE GEL PACK

Description of Event or Problem

2 BREG REUSABLE GEL PACKS WERE PLACED IN IT'S SLEEVE AND GIVEN TO THE PATIENT FOR COLD THERAPY AS THE PATIENT WAS ADMITTED WITH A FEMORAL NECK FRACTURE, AWAITING SURGERY THE FOLLOWING DAY. ON THE MORNING AFTER USING THE GEL PACKS, THE PATIENT REPORTED REDNESS ON HER LEFT THIGH WHERE THE COLD GEL PACKS WERE USED. THE PATIENT'S INJURY WAS EVALUATED BY THE PHYSICIAN AND WOUND CARE SPECIALIST NURSE, SILICONE DRESSING WAS USED FOR SKIN PROTECTION PER THEIR RECOMMENDATION. THE PATIENT HAD DEVELOPED REDNESS AND SMALL BLISTERS ON THE AREA BY THE TIME SHE WAS DISCHARGED 1 WEEK LATER. DISCUSSIONS WITH NURSING STAFF IDENTIFIED THAT THEY ARE FREQUENTLY SEEING AN ISSUE WITH THESE COLD GEL PACKS (SINCE THE TIME THIS PRODUCT WAS INTRODUCED AT OUR HOSPITAL IN [DATE REDACTED] - EARLIER THIS YEAR) AS THEY CONDENSE AND MAKE THE PATIENT'S SKIN OR SURGICAL DRESSINGS WET. THE STAFF REPORTED USING THE GEL PACKS AS PER MANUFACTURER'S RECOMMENDATION AND ALWAYS PLACE THEM IN THE BLACK/WHITE SLEEVE BEFORE PLACING GIVING THEM TO THE PATIENTS. MANUFACTURER RESPONSE FOR REUSABLE GEL PACK, BREG POLAR CARE (PER SITE REPORTER). THE VENDOR HAS BEEN NOTIFIED OF THE ISSUE. OUR NURSING MANAGER HAD A MEETING WITH THE VENDOR REP ON [DATE REDACTED] TO DISCUSS THE ISSUE. AS OF [DATE REDACTED] - TWO DAYS LATER, WE ARE AWAITING TO HEAR BACK FROM THE VENDOR/MANUFACTURER. WE HAVE THE PRODUCT WITH US. PLEASE SEND A PREPAID MAILING LABEL AND BOX IF YOU WOULD LIKE US TO MAIL THIS PRODUCT BACK TO YOU.