CEFALY

Additional Manufacturer Narrative

THIS INCIDENT AND THE ASSOCIATED FIELD CORRECTIVE ACTION OCCURRED IN UK,SWITZERLAND AND GERMANY, NOT IN THE USA. WE RECEIVED REPORTS FROM DISTRIBUTORS THAT USER EXPERIENCED A STRONG TINGLING SENSATION AT THE START OF TREATMENT. NO INJURIES WERE REPORTED, AND NONE OF THE USERS SOUGHT MEDICAL ATTENTION.THERE IS NO INDICATION THAT THE DEVICES CAUSED ANY SERIOUS INJURY. THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE. THE MANUFACTURER IS CURRENTLY AWAITING THE RETURN OF THE AFFECTED DEVICES FOR FURTHER ANALYSIS. IN THE MEANTIME, TESTING WAS CONDUCTED ON DEVICES FROM THE SAME LOT THAT REMAIN IN THE WAREHOUSE. DURING THESE TESTS, TWO INSTANCES OF HIGHER-THAN-NORMAL OUTPUT WERE OBSERVED: THE FIRST OCCURRED AT THE LOAD DETECTION STAGE. THE SECOND INSTANCE FOLLOWED APPROXIMATELY THREE SECONDS LATER, AT THE START OF TREATMENT. THESE ABNORMAL OUTPUTS MEASURED APPROXIMATELY 5-6 MA, EACH LASTING AROUND 200 MILLISECONDS. FOLLOWING THESE OCCURRENCES, THE DEVICES RETURNED TO NORMAL OPERATION, WITH THE GRADUAL RAMP-UP TO THE INTENDED MAXIMUM INTENSITY OF 16 MA PROCEEDING AS EXPECTED AS A PRECAUTIONARY MEASURE, A RECALL WILL BE INITIATED TO RETRIEVE THE AFFECTED DEVICES FROM USERS AND REPLACE THEM WITH FULLY FUNCTIONAL ONES. THIS STEP IS BEING TAKEN TO ENSURE USER SAFETY AND PREVENT ANY POTENTIAL RISK. FOLLOWING A ROOT CAUSE ANALYSIS, THE ISSUE HAS BEEN LINKED TO A SPECIFIC LOT OF CAPACITORS. DEVICES CONTAINING THIS SUSPECTED LOT OF CAPACITORS HAVE NOT BEEN SOLD IN THE USA. THEREFORE, NO RECALL OR FIELD SAFETY CORRECTIVE ACTION IS REQUIRED IN THE USA. UDI NUMBER OF DEVICES IN REPORT - GERMANY (B)(4). UDI NUMBER OF DEVICES IN REPORT - SWITZERLAND. (B)(4). UDI NUMBER OF DEVICE IN REPORT - UK. (B)(4).

Description of Event or Problem

TH INCIDENTS WERE OCCURRED IN GERMANY,UK AND SWITZERLAND , NOT IN THE USA. THE DISTRIBUTORS OF THOSE REGIONS HAVE INFORMED US THAT TOTAL NINE INCIDENTS THAT USERS REPORTED EXPERIENCING A STRONG TINGLING SENSATION AT THE START OF THE TREATMENT. NO INJURIES WERE REPORTED, AND THE USERS DID NOT SEEK MEDICAL ATTENTION IN ALL CASE . THERE IS NO INDICATION THAT THE DEVICES CAUSED ANY SERIOUS INJURY. THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE. THE MANUFACTURER IS CURRENTLY AWAITING THE RETURN OF THE AFFECTED DEVICES FOR FURTHER ANALYSIS. IN THE MEANTIME, TESTING WAS CONDUCTED ON DEVICES FROM THE SAME LOT STILL STORED IN THE WAREHOUSE. DURING THESE TESTS, TWO INSTANCES OF HIGHER-THAN-NORMAL OUTPUT WERE OBSERVED IN THE TESTED DEVICES : THE FIRST OCCURRED DURING THE LOAD DETECTION STAGE. THE SECOND OCCURRED APPROXIMATELY THREE SECONDS LATER, AT THE START OF THE TREATMENT PROGRAM. THESE ABNORMAL OUTPUTS MEASURED APPROXIMATELY 5-6 MA, EACH LASTING AROUND 200 MILLISECONDS. FOLLOWING THESE OCCURRENCES, THE DEVICES RETURNED TO NORMAL OPERATION, WITH THE GRADUAL RAMP-UP TO THE INTENDED MAXIMUM INTENSITY OF 16 MA PROCEEDING AS EXPECTED.