inforMED
InjuryNGX

COOLTONE SYSTEM

Received Dec 18, 2025 · Event occurred Nov 24, 2025

Report 3007215625-2025-00883 · MDR key 23845754

Device

Generic name

Stimulator, Muscle, Powered, For Muscle Conditioning

Catalog number

UNK COOLTONE

Lot number

NI

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • Burn(s)
  • Burn(s)

Narrative

Additional Manufacturer Narrative

NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING ANY TREATMENT OR MEDICAL INTERVENTION REQUIRED FOR THE REPORTED EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

Description of Event or Problem

HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT RECEIVED A COOTONE TREATMENT TO THE ABDOMEN AND PRESENTED WITH A "BURN" POST TREATMENT.