MAUDE Adverse Event Report: DJO LLC CHATTANOOGA; VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPL

Catalog Number	2761
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Unspecified Infection (1930)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that patient sustained 5 burns where electrodes were places during treatment that were treated topically by wound care using standard burn cream and infection treatments.The device has not been returned for evaluation, the root cause could not be established.If more information becomes available additional reporting on this event will be provided as a supplemental report to this document.
Event or Problem Description
It was reported that patient sustained 5 burns where electrodes were places during treatment that were treated topically by wound care using standard burn cream and infection treatments.
Additional Manufacturer Narrative
See d4 serial number, d9 and h11.The device has been returned and evaluated.Device passed all functional testing and is in good shape.Lead wires were tested and show good continuity.The root caused could have been from not properly preparing skin or using off brand accessories could cause burns under stim therapy.

• Brand Name: CHATTANOOGA
• Common Device Name: VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPL
• 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: 21940269
• Report Number: 9616086-2025-00048
• Device Sequence Number: 8534751
• Product Code: GZI
• UDI-Device Identifier: 00888912292849
• UDI-Public: 00888912292849
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: 2761
• Device Lot Number: 24L129
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/22/2025
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 85 KG