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

Device Problems Temperature Problem (3022); Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 12/14/2022

Event Type  Injury  

Event Description

It was reported that the unit allegedly caused a 2nd degree burn to patient during treatment.

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
• Type of Device: 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
• MDR Text Key: 308143668
• Report Number: 9616086-2023-00002
• Device Sequence Number: 1
• Product Code: IMG
• UDI-Device Identifier: 00888912292740
• UDI-Public: 00888912292740
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 61 KG