MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA INTELECT TRANSPORT 2CH STIM US STD; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number 2783

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

Patient Problem Lead(s), Burn(s) From (3161)

Event Date 01/19/2018

Event Type  Injury  

Manufacturer Narrative

Upon completion of an audit of the dj orthopedics (b)(4); fda issued a finding on 13 december 2018 that "procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established." this report is being submitted as part of djo's efforts to address this finding.One intelect advanced stim module (part number 2773ms, serial number (b)(4)) was returned for evaluation along with a set of four unknown brand electrodes.The unit passed functional testing.The lead wires tested within specified tolerance.However, the electrodes were tested but were not included in the final results due to unknown specifications.The electrodes were dirty and missing gel.

Event Description

It was reported that, while being treated for a left ankle sprain, the unit caused burns to the patient.There was reportedly no pain at the time of treatment.Blisters rose over the next 1-2 days.Patient reportedly noticed bleeding in the shower.Upon presenting to clinic again, the patient was provided with gause and medical tape, and was advised to seek medical attention at a walk-in clinic.Patient was prescribed two weeks of oral antibiotics and advised to keep the wound clean and dry.The chattanooga int advanced stim monochrome int'l std, part number 2773ms, is not marketed in the united states, but is substantially similar to a product that is marketed in the united states.Thus, it will be reported under chattanooga intelect transport 2ch stim us std, part number 2783.

Manufacturer Narrative

The device history record (dhr) was reviewed for the reported product with serial number (b)(4).There was no information in the dhr that would indicate a problem that contributed to the reported complaint.Complaint data for similar products and issues going back 9 months has been reviewed.The trend indicates that reported customer complaints are within control.

• Brand Name: CHATTANOOGA INTELECT TRANSPORT 2CH STIM US STD
• Type of Device: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8732107
• MDR Text Key: 149119014
• Report Number: 9616086-2019-00026
• Device Sequence Number: 1
• Product Code: IMG
• UDI-Device Identifier: 00888912293945
• UDI-Public: 00888912293945
• Combination Product (y/n): N
• PMA/PMN Number: K040285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

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: 2783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 06/25/2019
• Supplement Dates Manufacturer Received: 06/25/2019
• Supplement Dates FDA Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention