MAUDE Adverse Event Report: CHATTANOOGA GROUP INTELECT COMBO; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERA

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 01/16/2000

Event Type  malfunction  

Event Description

Stimulus machine caused burn on right chin.Approximate size 1/2 inch round burn at lead site.

Event Description

Stimulus machine caused burn on right shin.Approximate size 1/2 inch round burn at lead site.

• Brand Name: INTELECT COMBO
• Type of Device: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERA
• Manufacturer (Section D): CHATTANOOGA GROUP; 4717 adams rd; hixson TN 37343
• MDR Report Key: 3652621
• MDR Text Key: 4195417
• Report Number: 3652621
• Device Sequence Number: 1
• Product Code: IMG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/25/2014
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES