MAUDE Adverse Event Report: DJO LLC INTELECT LEGEND XT COMBOUS STD; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number	2760
Medical Device Problem Codes	Temperature Problem (3022); Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the unit allegedly caused a 2nd degree burn to patient during treatment.
Additional Manufacturer Narrative
It was reported that the unit allegedly caused a 2nd degree burn to patient during treatment.Enovis has received sufficient information regarding the reported 2nd degree burn.Several attempts have been made to request for the device to be returned for evaluation, but the device was not returned to enovis for evaluation.Enovis did receive a completed questionnaire for the reported injury.It was reported that there was an assessment of the patient's skin for cuts, bruises, open wounds, irritation, and incisions was performed prior to treatment.After treatment the patient had a burn mark on the skin under one electrode.There was no medical treatment at the time of the incident due to the injury.The patient saw their primary care physician who provided wound care and prescribed antibiotics.Additional reporting on this event will be provided as a supplemental report to this document if the device is returned or additional information is received.

• Brand Name: INTELECT LEGEND XT COMBOUS STD
• Common Device Name: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245 ; MX 22245
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 16244545
• Report Number: 9616086-2023-00002
• Device Sequence Number: 17793585
• Product Code: IMG
• UDI-Device Identifier: 00888912292740
• UDI-Public: 00888912292740
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K031077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2023

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: 2760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 61 KG