MAUDE Adverse Event Report: DYNATRONICS CORP. CHATTANOOGA OPERATIONS INTELLECT LEGEND 2C; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number INTCB¿2

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

Patient Problem Swelling (2091)

Event Date 09/25/2020

Event Type  malfunction  

Event Description

Patient received blister after therapy with device.Blister 1/8 cm circle.

• Brand Name: INTELLECT LEGEND 2C
• Type of Device: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DYNATRONICS CORP. CHATTANOOGA OPERATIONS; 7030 park centre dr.; salt lake city UT 84121
• MDR Report Key: 10851484
• MDR Text Key: 216627564
• Report Number: 10851484
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/16/2020,10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: INTCB¿2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2020
• Device Age: 15 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/17/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24820 DA