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

Model Number	5034
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
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
• Common Device Name: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• 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: 24649985
• Report Number: 8010720-2026-01792
• Device Sequence Number: 13208066
• 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: K253408
• 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): 03/20/2026

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 Model Number: 5034
• Device Catalogue Number: CS-MS-002-D-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2022
• 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