MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPL

Model Number	2761
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	11/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint received that alleges "during an interferential e-stem treatment for a muscle spasm on channel 2 and 3 a patient received a burn under two electrode pads.The patient was instructed that the intensity should be strong but not painful, and they needed to indicate when the intensity was sufficient for them, which he did so.About 2-3 minutes into the 12 minute treatment he asked for it to be turned down, which it was until he indicated it was a better intensity.About 3-4 minutes later he again asked for it to be turned down, which again it was until he indicated it was better.After about a minute he complained of it feeling hot/ burning despite not having any heat packs or ice associated with the treatment.He was told that was not normal, and he had the choice to continue with the treatment and keep turning it down, or that he could terminate the treatment.He chose to turn it down again, and after about 1 minute asked for it to be turned off.There was about 2 minutes left on the treatment.The treatment was given under his shirt to his rhomboid, the leads were removed and he went to the locker room.He returned to show me his burns, and his wounds were cleaned, treated with hydrocortisone cream and covered with a bandage.At the same time as his treatment another patient was receiving an ultrasound, stem combo treatment on channels 2 and the ultrasound head.There were no problems with the combo treatment administered.Follow-up with urgent care facility where he was told he had 3rd degree burns that would need future debridement and a referral to a wound care facility".Device not received manufacturer at this time.
Additional Manufacturer Narrative
Device evaluation report - the product met specifications and did not malfunction.

• Brand Name: CHATTANOOGA
• Common Device Name: VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPL
• Manufacturer (Section D): DJO, LLC; 1460 decision street; vista CA 92081 9663
• MDR Report Key: 7109689
• Report Number: 9616086-2017-00022
• Device Sequence Number: 1211611
• Product Code: IMG
• UDI-Device Identifier: 00888912292849
• UDI-Public: 00888912292849
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K031077
• 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,Followup
• Report Date (Section B): 12/12/2017

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: Medical Technologist
• Device Model Number: 2761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 06/14/2018
• 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