PULSETTO
Received Nov 10, 2025 · Event occurred Oct 28, 2025
Report MW5178703 · MDR key 23512044
Device
Generic name
Stimulator, Muscle, Powered
Manufacturer
PulsettoProduct problems
- Crack
- Material Frayed
- Melted
- Material Integrity Problem
Patient
52 YR · Male
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
USING PULSETTO VAGUS NERVE STIMULATOR HEAVILY MARKETED ON FACEBOOK AND SOCIAL MEDIA AND GAME ADS. FIRST DEVICE FLIMSY AND HOUSING CRACKED OPEN AND EXPOSED WIRING AND RETURNED FOR REPLACEMENT. ON (B)(6) I WAS USING REPLACEMENT DEVICE AND STARTED CHARGING IT. THE INDICATOR LIGHT STOPPED FLASHING AND I PICKED UP DEVICE AND BURNED MY HAND AND NOTED THE HOUSING WAS MELTING. THIS DEVICE IS POORLY CONSTRUCTED AND A FIRE AND INJURY HAZARD AND THIS COMPANY NEEDS TO BE HELD ACCOUNTABLE FOR PLACING PEOPLE AT RISK AND MAKING ALL THE CLAIMS THEY MAKE AND PUSH IN THEIR ADS. THERE ARE NO SERIAL NUMBERS THAT I CAN SEE AND ON INSISTENCE OF MANUFACTURER I HAVE SENT THE SECOND DEFECTIVE DEVICE BACK TO THE COMPANY.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED ON 11/12/2025 FOR REPORT MW5178703 TO ADD AN ADDITIONAL DEVICE. REFERENCE REPORT MW5178818. PT CODE: 2685. DEVICE CODE: 1437.