MAUDE Adverse Event Report: DR COMFORT, A DJO, LLC COMPANY CHATTANOOGA; INTELECT MOBILE COMBO, INT'L STD, 5CM APPL

Model Number 2778

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

Patient Problem Electric Shock (2554)

Event Date 11/10/2015

Event Type  Injury  

Manufacturer Narrative

Not yet returned.

Event Description

Complaint received that alleges "once technician believed the therapy session was completed she attempted to remove the electrodes from the patient.As she was removing the electrodes she sustained an electrical shock that gripped her hands, wrists and elbows sustained it in a flexed position.She was unable to release the electrodes until the machine was shut off by others in the room".Device not yet returned to manufacturer for evaluation.No indication event caused or contributed to permanent impairment or death.

• Brand Name: CHATTANOOGA
• Type of Device: INTELECT MOBILE COMBO, INT'L STD, 5CM APPL
• Manufacturer (Section D): DR COMFORT, A DJO, LLC COMPANY; 10300 enterprise drive; mequon 53092
• 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: 5501616
• MDR Text Key: 40363067
• Report Number: 9616086-2016-00008
• Device Sequence Number: 1
• Product Code: IPF
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K973024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2778
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2016
• 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