MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; INTELECT 4CH STIM PKG

Model Number	7560
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Lead(s), Burn(s) From (3161)
Date of Event	04/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not returned.
Event or Problem Description
Complaint received that alleges "electrodes were getting uncomfortably hot.The customer turned the unit down to level one, then turned the unit off.The electrodes shocked the customer as he removed the electrodes from the patient.The lower two electrodes were very hot.At the next visit the patient made customer aware of blisters at the site of the injury.The patient came in on friday (b)(6) 2016 with open wounds.Customer is calling a wound center".Questionnaire not received from clinician and/or patient.Device not returned to manufacturer for evaluation.

• Brand Name: CHATTANOOGA
• Common Device Name: INTELECT 4CH STIM PKG
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 5640861
• Report Number: 9616086-2016-00014
• Device Sequence Number: 13465030
• Product Code: IMI
• UDI-Device Identifier: 00888912372817
• UDI-Public: 00888912372817
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2016

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: No Information
• Device Model Number: 7560
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2016
• Initial Report FDA Received Date: 05/09/2016
• 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: Other