MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number 2761

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

Patient Problem No Code Available (3191)

Event Date 04/17/2019

Event Type  malfunction  

Event Description

Patient was being ultrasound with unit and reported a sensation of being stabbed with a needle.

• Brand Name: CHATTANOOGA
• Type of Device: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO, LLC; 1430 decision st; vista CA 92081
• MDR Report Key: 8568480
• MDR Text Key: 143682500
• Report Number: 8568480
• Device Sequence Number: 1
• Product Code: IMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/01/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15330 DA