MalfunctionEFS
CONAIR
Received Nov 16, 2023 · Event occurred Oct 24, 2023
Report 1222304-2023-00025 · MDR key 18147299
Device
Generic name
Oral Irrigator
Model number
WJXProduct problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(6) 2023 - THE CONSUMER ACCEPTED A REPLACEMENT AND WILL NOT BE RETURNING THE DEVICE BACK TO THE MANUFACTURER. THEREFORE, AN INVESTIGATION WILL NOT BE CONDUCTED.
Description of Event or Problem
(B)(6) 2023 - THE CONSUMER CLAIMS THERE WERE BLACK PARTICLES COMING OUT OF THE WAND. THE CONSUMER ACCEPTED A REPLACEMENT AND WILL NOT RETURN THE DEVICE TO THE MANUFACTUREER FOR AN INSPECTION.