MAUDE Adverse Event Report: CHATTANOOGA GROUP INC CHATTANOOGA CPS400

Model Number CPS400

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 07/01/2014

Event Type  Injury  

Event Description

Pt came into therapy on (b)(6) 2014 and stated that he had been burned on (b)(6) 2014 on his right leg after e-stim usage.Upon examination of the leg, a small circular wound with a white center was found by his knee.

• Brand Name: CHATTANOOGA CPS400
• Type of Device: CHATTANOOGA CPS400
• Manufacturer (Section D): CHATTANOOGA GROUP INC
• MDR Report Key: 3966592
• MDR Text Key: 21493655
• Report Number: MW5037499
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/24/2014

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: CPS400
• Other Device ID Number: 402934884
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR