REUSABLE GEL PACK SHOULDER, LARGE

Description of Event or Problem

A FIGHTECH AID PRO, REUSABLE GEL PACK (WWW.FIGHTECHGEAR.COM), SHOULDER-LARGE, (B)(6), MADE IN CHINA WAS PURCHASED FROM AMAZON. REUSABLE HOT AND COLD GEL ICE PACK FOR SHOULDER, ROTATOR CUFF, KNEE, BACK, HEAD, EYES, ELBOW, HIP - LEAK PROOF POST SURGERY HEAT & COLD THERAPY COMPRESS BY FIGHTECH (HINGE JOINT, SINGLE) HTTPS://WWW.AMAZON.COM/DP/B0BMSRH43S?REF=PPX_YO2OV_DT_B_FED_ASIN_TITLE. THE PACK WAS CHILLED AS PER INSTRUCTIONS. DURING USE ON THE PATIENT'S SHOULDER, THE PATIENT REPORTED IT LEAKED. AT THAT SITE IT CAUSED A SEVERE CHEMICAL SKIN BURN. RED NOTABLE INFLAMMATION. DISTINCT, IRREGULAR, BLOTCHY, MULTI-COLORED PATTERN WHERE THE LEAK WAS FELT. AREAS OF SKIN BLACKENED AND EVENTUALLY PEELED. PHOTOS WERE TAKEN OVER THE COURSE OF SEVERAL DAYS. NASTY. A PHYSICIAN WAS CONTACTED. LITTLE PAIN WAS REPORTED. THE BURN HEALED VERY SLOWLY. IT IS TOO EARLY TO KNOW IF PERMANENT SCARRING HAS TAKEN PLACE. THE PACK HAS BEEN RETAINED. THE PATIENT WISHES TO RETURN IT FOR A REFUND. PLEASE ADVISE SOONEST IF THE FDA WANTS THIS DEFECTIVE PRODUCT. PICTURES OF THE CHEMICAL BURN ARE AVAILABLE.