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

Model Number	5034
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020 allergan received a report regarding a patient who sustained an abdominal burn from a metal button on clothing worn during 2-minute cooltone treatments to both abdomen and buttocks.Prior to the cooltone treatment, the patient was also treated with a 5-minute session using emsculpt, a non-allergan product.It was stated that the patient's abdominal treatment area had decreased sensation due to prior abdominoplasty.The burn was diagnosed as 3rd degree and is healing well following debridement and topical antibiotics, corticosteroids, and scar-minimization ointments.The cooltone user manual states that metallic objects should be at least 1.2 meters away from the device and its accessories during use.Allergan is in contact with the treatment provider in order to obtain additional follow-up information.If additional information is received, the event will be re-assessed, and a follow-up report will be submitted.Based on the information currently available to the device importer, zeltiq aesthetics (allergan), a serious injury possibly caused by use error has occurred during cooltone treatment.An initial 30-day mdr was submitted by allergan to the fda on 06-mar-2020, with mfr report # 8010720-2020-00001.The said report number, however, was incorrect since it used the manufacturer fei and not the importer number.To correct this issue, this report was submitted with importer report # - 3007215625-2020-30000 and was tagged as an "initial report" for that report number.Section f - for use by user facility/importer, was also completed in this submission, all information obtained thus far was forwarded to the manufacturer, zimmer medizinsysteme (b)(4), which is the responsible party for completing the device investigation, root cause identification and determination if a device malfunction had occurred.

• Brand Name: COOLTONE
• Common Device Name: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm, 89231 ; GM 89231
• MDR Report Key: 9881201
• Report Number: 3007215625-2020-30000
• Device Sequence Number: 3419158
• Product Code: NGX
• UDI-Device Identifier: 04053815076698
• UDI-Public: (01)04053815076698
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2020
• Report Date (Section F): 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/11/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/07/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 03/25/2020