CHATTANOOGA 2841

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-02-11 for CHATTANOOGA 2841 manufactured by Djo, Llc.

Event Text Entries

[4457065] Complaint received from user facility that alleges "unit does not stop pulling". Product not received for evaluation or review. No additional information received from clinician/facility. Complaint did not indicate event caused or contributed to permanent impairment, injury or death. No patient involvement indicated in complaint.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9616086-2014-00004
• MDR Report Key: 3865205
• Report Source: 99
• Date Received: 2014-02-11
• Date of Report: 2014-02-10
• Date of Event: 2014-01-28
• Date Added to Maude: 2014-06-25
• 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 G1: DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
• Manufacturer Street: CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO
• Manufacturer City: TIJUANA B.C. 22244
• Manufacturer Country: MX
• Manufacturer Postal Code: 22244
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CHATTANOOGA
• Generic Name: TRITON DTS
• Product Code: ITH
• Date Received: 2014-02-11
• Catalog Number: 2841
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• 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		2014-02-11