LANSINOH THERAPEARL 3-IN-1 BREAST THERAPYPACK

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. 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. DEVICE PROBLEM OF BREAKAGE AS REPORTED WITHIN THIS EVENT HAS HISTORICALLY BEEN SEEN BY MISUSE OF THE DEVICE.

Description of Event or Problem

RB HEALTH (US), LLC WAS NOTIFIED OF AN ADVERSE EVENT INVOLVING THE LANSINOH THERAPEARL 3-IN-1 BREAST THERAPY PACK. THE USERS HUSBAND REPORTS THAT HIS WIFE IS BREASTFEEDING THEIR NEWBORN SON AND RECENTLY HAD MASTITIS IN HER RIGHT BREAST. THEY USED THE BREAST PACK AND REPORTED READING THE INSTRUCTIONS AND HEATING THE PACK UP CORRECTLY. THE HUSBAND STATED HIS WIFE APPLIED THE PACK WHICH WAS INTACT BUT SOON AFTER THE PACK SPLIT CAUSING THE HEATED PEARLS TO SPILL ONTO HER BREAST RESULTING IN A BURN WHICH REQUIRED HOSPITAL TREATMENT ON (B)(6) 2021.