THERAPEARL SPORTS PACK

Description of Event or Problem

RB HEALTH (US), LLC WAS NOTIFIED OF AN EVENT INVOLVING THE THERAPEARL SPORTS PACK. THE USER WITH STAGE 4 BREAST CANCER, HAS A CYST ON HER BREAST AND TRIED TO TREAT IT WITH THERAPEARL SPORTS PACK. THE USER DOES NOT KNOW THE WATTAGE ON HER MICROWAVE WHICH IS NECESSARY WHEN DETERMINING THE APPROPRIATE HEATING TIME FOR THE PACK. AFTER USING THE PACK FOR 3-4 MINUTES THE USER STATED SHE GOT A SECOND DEGREE BURN ON HER BREAST. THE USER STATED THAT HER DOCTOR PRESCRIBED ANTIBIOTIC CREAM AND MEDICATION. THERAPEARL SPORTS PACK IS A REUSABLE HOT/COLD PACK INTENDED FOR USE WITH COMMON ACHES, PAINS, SWELLING AND BRUISING.

Additional Manufacturer Narrative

AN INVESTIGATION ASSOCIATED WITH THIS COMPLAINT IS STILL ONGOING AND CONCLUSIONS HAVE NOT YET BEEN FINALIZED. DAMAGE TO THE PACK INCLUDING RUPTURE, BURSTS, AND OVERHEATING CAN OCCUR IF THE PACK IS HEATED BEYOND THE RECOMMENDED TIME AND/OR ON SETTINGS NOT RECOMMENDED BY THE MANUFACTURER. AS THE LOT WAS PLACED ON THE MARKET, MANUFACTURING SPECIFICATIONS NECESSARY FOR RELEASE WERE MET. THE PRODUCT IS LABELED WITH APPLICATION TIME FOR NO MORE THAN 20 MINUTES AND CAUTIONS THE USER TO ALWAYS TEST PACK TEMPERATURE PRIOR TO APPLICATION AS OVERHEATING OR PROLONGED APPLICATION MAY CAUSE INJURY, INCLUDING BURNS. SKIN REDNESS, SENSITIVITY AND BURNS ARE KNOWN RISKS OF USING LOCAL THERMOTHERAPY; THESE RISKS WERE EVALUATED IN THE PRODUCTS DFMEA. MISUSE OF THE DEVICE BY PROLONGED HEATING, EXPOSURE TO WATTAGES NOT DIRECTED WITHIN THE IFU, OR USE OF A DAMAGED PACK COULD CAUSE BURSTING OR BREAKAGE OF THE DEVICE. RISKS ARE REDUCED AS FAR AS POSSIBLE.