MAUDE Adverse Event Report: DJO LLC CHATTANOOGA; VECTRA GENISYS 2CH COMBO, US STD W/CART

Catalog Number	2792
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient was receiving electrical stimulation, upon completion of treatment and inspection of skin after electrical stimulation.The physical therapist assistant noted skin alterations and notified their supervisor of the findings.The device has not been returned for evaluation; the rood cause could not be established.If more information becomes available additional reporting will be provided as a supplemental report to this document.
Event or Problem Description
It was reported that the patient was receiving electrical stimulation, upon completion of treatment and inspection of skin after electrical stimulation.The physical therapist assistant noted skin alterations and notified their supervisor of the findings.

• Brand Name: CHATTANOOGA
• Common Device Name: VECTRA GENISYS 2CH COMBO, US STD W/CART
• 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 lobre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245, mex 22245 ; MX 22245
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 21532028
• Report Number: 9616086-2025-00022
• Device Sequence Number: 17916992
• Product Code: IMG
• UDI-Device Identifier: 00888912294447
• UDI-Public: 00888912294447
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2025

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 Catalogue Number: 2792
• Device Lot Number: T3000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/05/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown