MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; VECTRA GEN 2C COMBO W/O EMG PK US STD

Model Number 2872

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chest Pain (1776)

Event Date 08/25/2016

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Complaint received that alleges "patient taken to the er due to chest pains that began during treatment".Questionnaire was received from customer or clinician.Treatment was interrupted, progress towards recovery was not impeded.Patient requested treatment stop when feeling chest pains approximately one minute into treatment, vitals were wnl, was transported to er for evaluation.Device not returned to manufacturer for evaluation.

• Brand Name: CHATTANOOGA
• Type of Device: VECTRA GEN 2C COMBO W/O EMG PK US STD
• 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: 5908286
• MDR Text Key: 53137527
• Report Number: 9616086-2016-00023
• Device Sequence Number: 1
• Product Code: IMG
• UDI-Device Identifier: 00888912296854
• UDI-Public: 00888912296854
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 185