MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; VECTRA GENISYS

Model Number 2761

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Pain (1994); Discomfort (2330); Deformity/ Disfigurement (2360)

Event Date 06/07/2013

Event Type  Injury  

Event Description

Complaint received via law suit that alleges "painful burns to multiple areas of his back, permanent disfigurement to the skin on his back, expects to continue to suffer pain, discomfort, and embarrassment".Questionnaire was not received from clinician and/or patient.

• Brand Name: CHATTANOOGA
• Type of Device: VECTRA GENISYS
• Manufacturer (Section D): DJO, LLC; 1430 decision street; 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 street; vista, CA 92081 ; 7607271280
• MDR Report Key: 4861460
• MDR Text Key: 5862020
• Report Number: 9616086-2015-00016
• Device Sequence Number: 1
• Product Code: IMG
• 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: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• 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?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other