COOLTONE SYSTEM
Received Sep 10, 2025 · Event occurred Aug 19, 2025
Report 3007215625-2025-00657 · MDR key 23022863
Device
Generic name
Stimulator, Muscle, Powered, For Muscle Conditioning
Manufacturer
Zimmer Medizinsysteme GmbhCatalog 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
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
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
ALLERGAN AESTHETICS RECEIVED A REPORT FROM A PATIENT WHO RECEIVED COOLTONE TREATMENT IN (B)(6) 2024, AND HAD SEVERE PAIN IN THE RIGHT THIGH AND STOPPED TREATMENT. REPORTER INDICATED THAT THE PATIENT WENT TO SEE A SPORTS MEDICINE DOCTOR AND WAS DIAGNOSED WITH TENDON TEAR FROM BONE. IT WAS REPORTED THAT THE PATIENT LOST ALL THE MUSCLE IN THE THIGHS AND BUTTOCKS BECAUSE OF THIS. THOUGH REQUESTED, ADDITIONAL EVENT INFORMATION WAS NOT PROVIDED BY THE PATIENT.