COOLTONE
Received Dec 22, 2025 · Event occurred Nov 24, 2025
Report 0008010720-2025-01788 · MDR key 23864498
Device
Generic name
Stimulator, Muscle, Powered, For Muscle Conditioning, Product Code: Ngx
Manufacturer
Zimmer Medizinsysteme GmbhModel number
5034Catalog number
CS-MS-002-D-00
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. 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. DISTRIBUTOR TRIED TO CONTACT HEALTHCARE PROVIDER TO COLLECT MORE INFORMATION WITHOUT RESULT. SO, CIRCUMSTANCES AND DEGREE OF BURN UNKNOWN.