NEEDLE ELECTRODE
Received Jan 22, 2021 · Event occurred Oct 21, 2020
Report 1222993-2021-00002 · MDR key 11216565
Device
Product problems
- Device Dislodged or Dislocated
- Device Dislodged or Dislocated
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO PATIENT INJURY WAS REPORTED. ALTHOUGH ADDITIONAL TREATMENT INFORMATION WAS REQUESTED, THERE WAS NO ADDITIONAL INFORMATION MADE AVAILABLE FROM THE CUSTOMER SITE DESPITE MULTIPLE REQUESTS. THE DEVICE HISTORY RECORD CONFIRMS THAT THE PRODUCT PASSED AND MET ALL REQUIREMENTS BEFORE RELEASING. IF THIS INCIDENT WERE TO RECUR, THERE IS A POSSIBILITY OF PATIENT INJURY LEADING TO PERMANENT IMPAIRMENT OF A BODY STRUCTURE AND THERE THIS INCIDENT IS REPORTABLE. IF ADDITIONAL RELEVANT DATA BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE ELECTRODE NEEDLE DISENGAGED FROM THE ELECTRODE HOLDER AND FELL INTO THE PATIENT'S MOUTH.