SOMNODENT

Description of Event or Problem

SOMNOMED ORAL DEVICE FOR SLEEP APNEA CRACKED ON BOTTOM. SOMNOMED HAS LITTLE TO NO REVERSE LOGISTICS FOR REPAIR IN MY OPINION. MY DENTIST HAD GONE OUT OF BUSINESS, SOMNOMED HAD NO PROCESS FOR FINDING REPAIR FACILITY. THE COMPANY INSULTED ME THE CUSTOMER, TOOK DAYS TO RESPOND FOR REQUESTS FOR HELP. THIS DEVICE PREVENTS SLEEP APNEA WHICH WE KNOW CAN CAUSE SUDDEN DEATH. ONCE A DENTIST WAS FOUND, A VERY POOR QUALITY AND NON FITTING ORAL TEMPORARY DEVICE WAS PROVIDED. TOLD REPAIR WILL TAKE UP TO 3 WEEKS, IN THE MEANTIME I AM LEFT AT HIGH RISK OF SLEEP APNEA RELATED ISSUES. TO INCLUDE I AM CURRENTLY RECEIVING LITTLE TO NO SLEEP. ISSUES FOR FDA ARE: COMPANY NEEDS A RESPONSE PROCESS IN PLACE FOR RETURNS RELATED TO THE FAILURE OF THEIR RENEW SLEEP BUSINESS; THE COMPANY MUST PROVIDE A TEMPORARY DEVICE THAT FITS THE PATIENT AND PREVENTS SLEEP APNEA WHILE REPAIR IS MADE BECAUSE, COMPANY SHOULD NOT HAVE A 3 WEEK LEAD TIME FOR A MEDICAL DEVICE THAT PREVENTS LIFE THREATENING ISSUES. COMPANY CURRENTLY HAS THE PRODUCT, SO UNABLE TO PROVIDE SERIAL NUMBER. FDA SAFETY REPORT ID# (B)(4).