MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; HYDROCOLLATOR

Model Number 2502

Device Problems Thermal Decomposition of Device (1071); Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2015

Event Type  malfunction  

Event Description

Complaint received from clinician that alleges "customer states that the unit caught fire and the back power cord plug along with the back panel of the unit was burnt up.No injury occurred".Questionnaire was not received from clinician and/or patient.Device not returned to manufacturer for evaluation.No indication event caused or contributed to permanent impairment or death.

Manufacturer Narrative

Device not returned to manufacturer.

• Brand Name: CHATTANOOGA
• Type of Device: HYDROCOLLATOR
• 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, mexico 2224 4; MX 22244
• Manufacturer Contact: robert virgadamo ; 1430 decision st.; vista, CA 92081 ; 7607271280
• MDR Report Key: 4725287
• MDR Text Key: 20360832
• Report Number: 9616086-2015-00009
• Device Sequence Number: 1
• Product Code: IME
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2502
• Device Catalogue Number: 2502
• 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