MAUDE Adverse Event Report: DJO LLC LEGEND XT 2CH STIM PKG; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number	2763
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the unit applicator allegedly burned the patient on the neck area.The biomed claims per statements of clinical staff this might have been a user error.
Additional Manufacturer Narrative
It was reported that the unit applicator allegedly burned the patient on the neck area.The biomed claims per statements of clinical staff this might have been a user error.Djo is evaluating this device.Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
It was reported that the unit applicator allegedly burned the patient on the neck area.The biomed claims per statements of clinical staff this might have been a user error.Djo is evaluating this device.After performing functional and electrical testing, the technician was unable to duplicate the reported complaint.The product met manufacturer specifications.Possible root causes include moisture or misapplication of the electrodes.

• Brand Name: LEGEND XT 2CH STIM PKG
• 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: 13805737
• Report Number: 9616086-2022-00003
• Device Sequence Number: 4029661
• Product Code: IMG
• UDI-Device Identifier: 00888912293013
• UDI-Public: 00888912293013
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,Followup
• Report Date (Section B): 04/25/2022

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: 2763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown