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 Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 05/04/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the therapist treated the patient for injuries with a stimulation device and treatment to help alleviate pain and discomfort in the patient's back, and allegedly burned the plaintiff causing serious pain, discomfort and permanent disfigurement by seriously scarring on the patient's shoulder.Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

It was reported that the therapist treated the patient for injuries with a stimulation device and treatment to help alleviate pain and discomfort in the patient's back, and allegedly burned the plaintiff causing serious pain, discomfort and permanent disfigurement by seriously scarring on the patient's shoulder.

• 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; suite 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 ; 2900 lake vista drive; suite 200; lewisville, TX 75067 ; 5126088462
• MDR Report Key: 17121796
• MDR Text Key: 317124470
• Report Number: 9616086-2023-00026
• 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: 06/09/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 2760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/13/2023
• 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): Required Intervention