inforMED
MalfunctionIPF

PULSETTO

Received Jun 17, 2026 · Event occurred Jun 3, 2026

Report MW5189519 · MDR key 25531873

Device

Generic name

Stimulator, Muscle, Powered

Manufacturer

Pulsetto

Patient

38 YR · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

NO HARM ACTUALLY OCCURRED, BUT THE PRODUCT BUSTED. I AM FILING THIS COMPLAINT BECAUSE PULSETTO IS CONDITIONING MY 2-YEAR MANUFACTURING WARRANTY REPLACEMENT ON A DEMAND THAT I VIOLATE FEDERAL TRANSIT SAFETY LAWS. MY PULSETTO DEVICE SUFFERED A THERMAL FAILURE WHILE CHARGING, WHICH PHYSICALLY MELTED AND DEFORMED THE PLASTIC HOUSING. I PROVIDED PHOTOGRAPHIC PROOF TO CUSTOMER SUPPORT. UNDER DEPARTMENT OF TRANSPORTATION REGULATIONS (49 CFR § 173.185(F)) AND USPS PUBLICATION 52, SECTION 349.21(G), A THERMALLY COMPROMISED, MELTED LITHIUM-ION BATTERY IS STRICTLY PROHIBITED FROM STANDARD MAIL STREAMS WITHOUT A CUSTOM HAZARD WAIVER OR A CERTIFIED DOT SPECIAL PERMIT BOX. PULSETTO ISSUED A STANDARD USPS GROUND ADVANTAGE LABEL AND EXPLICITLY STATED IN WRITING THAT THE DEVICE 'IS NOT CLASSIFIED AS HAZARDOUS WASTE' AND REFUSED TO HONOR THE WARRANTY UNLESS I MAILED THIS BACK TO THEM. I REFUSED TO ENDANGER POSTAL WORKERS. BECAUSE THE COMPANY REFUSED TO ALLOW SAFE LOCAL E-WASTE DISPOSAL WITH PROOF OF RECEIPT, I HAVE FILED FORMAL SAFETY REPORTS WITH THE U.S. DEPARTMENT OF TRANSPORTATION (DOT) PHMSA ENFORCEMENT DIVISION AND THE CONSUMER PRODUCT SAFETY COMMISSION (CPSC), BUT THEY TOLD ME YOU HAVE JURISDICTION INSTEAD. I RECEIVED A REFUND FOR MY INITIAL PURCHASE, BUT AM WAITING ON A REFUND FOR THE APP SUBSCRIPTION THAT OCCURRED THE DAY IT WENT DEFECTIVE. I REQUIRE PULSETTO TO COMPLETELY CANCEL THE RETURN REQUIREMENT AND ACCEPT THE CHARGEBACK WITHOUT CONTESTING IT.