MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; INTELECT COMBO PACKAGE

Model Number INTC B

Device Problem Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 10/06/2015

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Complaint received that alleges "the unit has burned a patient".Product not returned for evaluation.Product questionnaire received from clinician and/or patient.Event did interrupt treatment, recovery was impeded.Patient received third degree burn under 1 electrode, superficial burn under one electrode.Patient received treatment at the time of the incident, and was referred for follow up with doctor post event.

Manufacturer Narrative

Product was returned for review.The product malfunctioned or failed to meet specifications.The malfunction or failure is not related to the event.No problems were duplicated that may have caused or contributed to the event.All treatments were run for full duration and no problems were duplicated.

• Brand Name: CHATTANOOGA
• Type of Device: INTELECT COMBO PACKAGE
• 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, mexico 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081 ; 7607313126
• MDR Report Key: 5212279
• MDR Text Key: 30830795
• Report Number: 9616086-2015-00028
• Device Sequence Number: 1
• Product Code: IPF
• 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,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: INTC B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention