MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; VECTRA GENISYS 2CH COMBO PKG

Model Number 2761

Device Problem Insufficient Information (3190)

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

Event Type  No Answer Provided  

Event Description

Complaint received from clinic that alleges "patient received third degree burns during stim treatment." product not received by manufacturer for review.Product questionnaire not received from clinician and/or patient.Complaint alleges event caused or contributed to permanent impairment, injury or death.Complaint alleges device caused or contributed to the event.

• Brand Name: CHATTANOOGA
• Type of Device: VECTRA GENISYS 2CH COMBO PKG
• 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: 3631966
• MDR Text Key: 16687164
• Report Number: 9616086-2014-00003
• Device Sequence Number: 1
• Product Code: GZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2761
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other