MAUDE Adverse Event Report: ZIMMER MEDIZINSYSTEME GMBH COOLTONE; STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING, PRODUCT CODE: NGX

Model Number	5034
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
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.

• Brand Name: COOLTONE
• Common Device Name: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING, PRODUCT CODE: NGX
• Manufacturer (Section D): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm, bavaria 89231 ; GM 89231
• Manufacturer (Section G): ZIMMER MEDIZINSYSTEME GMBH; leibnizstrasse 9; neu-ulm, bavaria 89231 ; GM 89231
• Manufacturer Contact: stefan leinweber ; junkersstrasse 9; neu-ulm, bavaria 89231 ; GM 89231
• MDR Report Key: 23864498
• Report Number: 0008010720-2025-01788
• Device Sequence Number: 13113900
• Product Code: NGX
• UDI-Device Identifier: 04053815076698
• UDI-Public: 04053815076698
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K251378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 5034
• Device Catalogue Number: CS-MS-002-D-00
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown