MAUDE Adverse Event Report: DJO LLC CHATTANOOGA; INTELECT RPW 2 120V, USA KIT

Catalog Number	2176KIT
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reports injury to customer, customer reported friction type burns on her right-side mid back days after treatment with rpw2 2176kit sn (b)(6).Customer reports no anomalies with unit, no medical treatment rendered.
Additional Manufacturer Narrative
Customer reports injury to customer, customer reported friction type burns on her right-side mid back days after treatment with rpw2 2176kit sn (b)(6).Customer reports no anomalies with unit, no medical treatment rendered.The device has not been returned for evaluation, the root cause could not be confirmed additional reporting on this event will be provided as a supplemental report to this document if more information becomes available.

• Brand Name: CHATTANOOGA
• Common Device Name: INTELECT RPW 2 120V, USA KIT
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad, ca 92010 ; CH 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: 23737952
• Report Number: 9616086-2025-00072
• Device Sequence Number: 8835742
• Product Code: ISA
• UDI-Device Identifier: 00190446673170
• UDI-Public: 00190446673170
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: D426765
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2025

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: 2176KIT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Female