MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA INTELECT TRANSPORT COMBO PKG US STD; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number 2738

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

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

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.

Event Description

It was reported that the patient was burned while on electrotherapy treatment.Patient got a blister that was treated immediately.Unit did not display any error codes.Unit was just recently inspected and came back with everything working fine.Customer was not aware when was the last time lead wire and electrodes were changed.No further information has been provided.

• Brand Name: CHATTANOOGA INTELECT TRANSPORT COMBO PKG US STD
• Type of Device: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• 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: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 8959563
• MDR Text Key: 156403824
• Report Number: 9616086-2019-00059
• Device Sequence Number: 1
• Product Code: IMG
• UDI-Device Identifier: 00888912021883
• UDI-Public: 00888912021883
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 2738
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention