MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA INTELECT TRANSPORT COMBO PKG US STD; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number	2738
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of an audit of the dj orthopedics (b)(4), fda issued a finding on 13 december 2018 that "procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established." this report is being submitted as part of djo's efforts to address this finding.Device evaluated by mfr: one intelect transport combo (part number 2738, serial number (b)(4)) and one 5cm applicator (part number 27383, serial number (b)(4)) were returned for evaluation.Unit and applicator passed functional testing.Lead wires tested within tolerance.No fault was found with the returned unit and applicator.No electrodes were sent in for evaluation.The device history record (dhr) was reviewed for the reported product.There was no information in the dhr that would indicate a problem that contributed to the reported complaint.Complaint data for similar products and issues going back 9 months has been reviewed.The trend indicates that reported customer complaints are within control.
Event or Problem Description
It was reported that the patient was burned by the electrodes while using the transport unit.Pictures indicate a second-degree burn.Further information was requested but not provided.

• Brand Name: CHATTANOOGA INTELECT TRANSPORT COMBO PKG US STD
• Common Device Name: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8734872
• Report Number: 9616086-2019-00044
• Device Sequence Number: 16724687
• Product Code: IMG
• UDI-Device Identifier: 00888912021883
• UDI-Public: 00888912021883
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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: 2738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 06/26/2019
• 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