CEFALY
Received Apr 8, 2024 · Event occurred Mar 8, 2024
Report 3010188009-2024-00002 · MDR key 19061980
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
40 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THIS DOCUMENT IS A PRELIMINARY REPORT BASED ON THE INFORMATION CURRENTLY AVAILABLE, PREPARED WITH CAREFUL CONSIDERATION. AT THIS TIME, THERE IS NO EVIDENCE INDICATING THAT THE ISSUE IS DUE TO A MALFUNCTION OF THE CEFALY PRODUCT. THE DEVICE HAS BEEN RETURNED BY THE CUSTOMER AND IS NOW ON ITS WAY TO THE FACTORY FOR A THOROUGH INVESTIGATION. A DETAILED UPDATE WILL BE PROVIDED AFTER THE DEVICE HAS BEEN CLOSELY EXAMINED. THE CUSTOMER REPORTED THAT THEY DISCOVERED THE DEVICE WAS MELTED OVERNIGHT WHILE CHARGING . CUSTOMER SAID LAST USED THE DEVICE LAST WEEK OF THE INCIDENT AND AT THAT TIME THE DEVICE WERE FINE.
Additional Manufacturer Narrative
THE TEAM HAS SENT THE DEVICE TO THE FACTORY FOR ANALYSIS. EFFORTS ARE ALSO UNDERWAY TO REACH OUT TO THE USER TO GATHER THE PATIENT'S DETAILS AS OUTLINED IN SECTION A. IT'S IMPORTANT TO NOTE THAT THE AGE AND WEIGHT INFORMATION WE HAVE NOW IS ESTIMATED AND WILL BE CONFIRMED DIRECTLY WITH THE PATIENT. PLEASE NOTE THAT THIS INFORMATION MAY BE UPDATED.