MAUDE Adverse Event Report: DJO LLC CHATTANOOGA INTELECT XT 4CH COMBO, US STD; INTERFERENTIAL CURRENT THERAPY

Model Number 2760

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that during interferential treatment, the customer allegedly received an overcharge and reported a second degree burn.A djo service and repair technician went onsite to perform an evaluation on the 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.

Event Description

It was reported that during interferential treatment, the customer allegedly received an overcharge and reported a second degree burn.

• Brand Name: CHATTANOOGA INTELECT XT 4CH COMBO, US STD
• Type of Device: INTERFERENTIAL CURRENT THERAPY
• Manufacturer (Section D): DJO LLC; 1430 decision street; vista 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S. A. DE C. V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, b.c. 22244 ; MX 22244
• Manufacturer Contact: jim pomeroy ; 1430 decision street; vista, CA 92081 ; 5128346301
• MDR Report Key: 11313233
• MDR Text Key: 231371799
• Report Number: 9616086-2021-00001
• Device Sequence Number: 1
• Product Code: LIH
• UDI-Device Identifier: 00888912292740
• UDI-Public: 00888912292740
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/11/2021

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
• Device Operator: Health Professional
• Device Model Number: 2760
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other