InjuryEGJ
CHATTANOOGA IOGEL MEDIUM 2.5 CC ELECTRODE
Received Nov 5, 2020 · Event occurred Sep 16, 2020
Report 9616086-2020-00032 · MDR key 10791192
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Burn(s)
- Full thickness (Third Degree) Burn
- Burn(s)
- Full thickness (Third Degree) Burn
Narrative
Additional Manufacturer Narrative
HEALTH PROFESSIONAL, OCCUPATION: UNKNOWN. DEVICE NOT RECEIVED MANUFACTURER AT THIS TIME. MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED THAT THE "ELECTRODES BURNED A PATIENT AND TWO SMALL BLISTERS THAT PROGRESSED TO A THIRD DEGREE BURN." THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.