CHATTANOOGA 2761

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-19 for CHATTANOOGA 2761 manufactured by Djo, Llc.

Event Text Entries

[5862020] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9616086-2015-00016
• MDR Report Key: 4861460
• Report Source: 05
• Date Received: 2015-06-19
• Date of Report: 2014-06-19
• Date of Event: 2013-06-07
• Date Added to Maude: 2015-06-24
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: 1430 DECISION STREET
• Manufacturer City: VISTA CA 92081
• Manufacturer Country: US
• Manufacturer Postal: 92081
• Manufacturer Phone: 7607271280
• Manufacturer G1: DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
• Manufacturer Street: CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO
• Manufacturer City: TIJUANA 22244
• Manufacturer Country: MX
• Manufacturer Postal Code: 22244
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CHATTANOOGA
• Generic Name: VECTRA GENISYS
• Product Code: IMG
• Date Received: 2015-06-19
• Model Number: 2761
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DJO, LLC
• Manufacturer Address: 1430 DECISION STREET VISTA CA 92081 US 92081

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-06-19