MAUDE Adverse Event Report: DJO LLC. CHATTANOOGA IOGEL MEDIUM 2.5 CC ELECTRODE; DEVICE, IONTOPHORESIS, OTHER USES

Model Number	5000022
Health Effect - Clinical Codes	Burn(s) (1757); Full thickness (Third Degree) Burn (2696)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health professional, occupation: unknown.Device not received manufacturer at this time.Manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
It was reported that the "electrodes burned a patient and two small blisters that progressed to a third degree burn." the device has not been returned for evaluation.There is no additional information available at this time.

• Brand Name: CHATTANOOGA IOGEL MEDIUM 2.5 CC ELECTRODE
• Common Device Name: DEVICE, IONTOPHORESIS, OTHER USES
• Manufacturer (Section D): DJO LLC.; 1430 decision street; vista CA 92081
• MDR Report Key: 10791192
• Report Number: 9616086-2020-00032
• Device Sequence Number: 3569628
• Product Code: EGJ
• UDI-Device Identifier: 00888912151412
• UDI-Public: 00888912151412
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 5000022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Other