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

Catalog Number	CS-MS-002-D-00
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Caustic/Chemical Burns (2549)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer medizinsysteme gmbh is the manufacturer of the device, zimmer medizinsysteme gmbh has been notified of the event.A supplemental report will be submitted if additional information is obtained.
Event or Problem Description
Healthcare professional reported that a patient received a cooltone treatment on (b)(6) 2026 using the cooltone applicator on the abdomen area.During the 22-minute treatment, the paddle leaked all over patient, including into their genitalia and bilateral upper leg.The patient experienced redness on the abdomen post treatment that worsened after a few minutes.Healthcare professional is considering sending the patient to the emergency room.Healthcare professional later reported "the customer's skin became red after the leak was noticed, poison control notified, sent to the emergency department as recommended by poison control".

• Brand Name: COOLTONE SYSTEM
• Common Device Name: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm ; GM
• Manufacturer (Section G): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm ; GM
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 24591093
• Report Number: 3007215625-2026-00117
• Device Sequence Number: 21164938
• Product Code: NGX
• UDI-Device Identifier: 04053815076698
• UDI-Public: (01)04053815076698(11)230522(17)991231
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K192940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2026
• Report Date (Section F): 03/12/2026

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 Catalogue Number: CS-MS-002-D-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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 Age: 40 YR
• Patient Sex: Female