INTELECT COMBO *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-25 for INTELECT COMBO * manufactured by Chattanooga Group.

Event Text Entries

[4281147] Stimulus machine caused burn on right shin. Approximate size 1/2 inch round burn at lead site.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3652621
• MDR Report Key: 3652621
• Date Received: 2014-02-25
• Date of Report: 2014-02-25
• Date of Event: 2000-01-16
• Report Date: 2014-02-25
• Date Reported to FDA: 2014-02-25
• Date Reported to Mfgr: 2014-02-28
• Date Added to Maude: 2014-02-28
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INTELECT COMBO
• Generic Name: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERA
• Product Code: IMG
• Date Received: 2014-02-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CHATTANOOGA GROUP
• Manufacturer Address: 4717 ADAMS RD HIXSON TN 37343 US 37343

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-02-25