MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; STEAM PACK NCP PACKAGED SINGLE

Model Number 1002

Device Problems Thermal Decomposition of Device (1071); Charred (1086); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Not Applicable (3189)

Event Date 12/30/2015

Event Type  malfunction  

Manufacturer Narrative

Not returned.

Event Description

Complaint received that alleges "the hotpac that they received, they stuck in water and a microwave safe container.They set the microwave for a minute and that was not enough so they put it on longer and the hotpac caught on fire." 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.

• Brand Name: CHATTANOOGA
• Type of Device: STEAM PACK NCP PACKAGED SINGLE
• 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: 5357567
• MDR Text Key: 35986936
• Report Number: 9616086-2016-00002
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1002
• Was Device Available for Evaluation?: Yes
• 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