MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; FLUIDOTHERAPY

Model Number FLU115D

Device Problem Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 01/09/2015

Event Type  Injury  

Event Description

Complaint received from fda medwatch program that alleges "during treatment, the patient complained of temperature being too hot and temp was turned down and patient left to continue treatment.When patient was taken out of the device, it was noticed that his right 5th digit (from the pip joint to the finger tip) was burned to the point that the skin was actually off finger.Burn "get" was placed on finger with loose gauze, patient was escorted to ed for further evaluation (no ed details available to djo)".Questionnaire was not received from clinician and/or patient.Device was not returned to mfr for evaluation.Mw ref#: 5040428.

• Brand Name: CHATTANOOGA
• Type of Device: FLUIDOTHERAPY
• Manufacturer (Section D): DJO, LLC; 1430 decision st; vista CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, 2224 4; MX 22244
• Manufacturer Contact: 1430 decision st; vista, CA 92081 ; 7607271280
• MDR Report Key: 4824897
• MDR Text Key: 16634793
• Report Number: 9616086-2015-00013
• Device Sequence Number: 1
• Product Code: LSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FLU115D
• Was Device Available for Evaluation?: No
• 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): Other