MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; INTELECT TRANSPORT COMBO PKG US STD

Model Number 2738

Device Problems Self-Activation or Keying (1557); Failure to Shut Off (2939); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 09/21/2015

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

Complaint received that alleges "they were doing an e-stim treatment and the unit's intensity continued to increase without anyone turning it up.This caused pain in the resident and when they tried to turn it off, they couldn't and had to pull off the electrodes which then shocked the therapist.The resident has experience constant pain throughout the weekend where the pads were attached.The patient is going to see their primary dr.For these injuries".Questionnaire was not received from clinician and/or patient.Device not returned to manufacturer for evaluation.No indication event caused or contributed to permanent impairment or death.No indication device caused or contributed to the event.

Manufacturer Narrative

Product was returned for review.The product met specifications and did not malfunction.The unit and applicator passed all functional and cosmetic testing.No accessories were included for evaluation (leadwires, electrodes).Additional information does not change original not reportable decision.

• Brand Name: CHATTANOOGA
• Type of Device: INTELECT TRANSPORT COMBO PKG 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: 5114211
• MDR Text Key: 27172977
• Report Number: 9616086-2015-00026
• Device Sequence Number: 1
• Product Code: IPF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Service Personnel
• Type of Report: Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2738
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• 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