MAUDE Adverse Event Report: DJO GLOBAL / DJO, LLC INTELECT LEGEND XT COMBO (CHATTANOOGA) ELECTRICAL STIMULATION; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number 2760

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

Patient Problem Skin Tears (2516)

Event Date 12/24/2020

Event Type  Injury  

Event Description

Patient received electrical stimulation for pain management on (b)(6) 2020, (b)(6) 2020, (b)(6) 2020, (b)(6) 2020, and (b)(6) 2020.On (b)(6) 2020 when patient was to be seen for electrical stimulation staff noticed that the patient's skin was not intact.Fda safety report id#: (b)(4).

• Brand Name: INTELECT LEGEND XT COMBO (CHATTANOOGA) ELECTRICAL STIMULATION
• Type of Device: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO GLOBAL / DJO, LLC; vista CA 92081
• MDR Report Key: 11243375
• MDR Text Key: 229625897
• Report Number: MW5099045
• Device Sequence Number: 1
• Product Code: IMG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR
• Patient Weight: 93