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 Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9616086-2023-00026
• Device Sequence Number: 6650016
• Product Code: IMG
• UDI-Device Identifier: 00888912292740
• UDI-Public: 00888912292740
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/13/2023
• 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: Required Intervention
• Patient Sex: Unknown