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

Model Number	5034
Medical Device Problem Codes	Crack (1135); Overheating of Device (1437)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	09/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Allergan aesthetics received a report of a patient treated abdomen on (b)(6) 2025 using the cooltone applicator and presented with blanching/redness immediately after treatment and then the patient presented with blister.Practice believes 2nd-3rd degree burn.Later provider reported overheating applicator and "applicator is warped, cracked, and bulging out".Applicator was replaced.Device remains at the user facility.Tee report was forwarded to manufacturer zimmer medizinsysteme gmbh.

• 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: 23486787
• Report Number: 8010720-2025-01781
• Device Sequence Number: 10526824
• Product Code: NGX
• UDI-Device Identifier: 04053815076698
• UDI-Public: 04053815076698
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/06/2025

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?: Yes
• 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: 10/23/2025
• Initial Report FDA Received Date: 11/06/2025
• 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; Other
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 88 KG