CONAIR
Received Dec 13, 2022 · Event occurred Nov 13, 2022
Report 1222304-2022-00038 · MDR key 15969556
Device
Product problems
- Fail-Safe Problem
- Appropriate Device Problem Term/Code Not Available
- Fail-Safe Problem
- 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) 2022: THE CONSUMER ACCEPTED A REPLACEMENT PRODUCT AND WILL NOT RETURN THE DEVICE. THEREFORE AN INVESTIGATION WILL NOT OCCUR.
Description of Event or Problem
(B)(6) 2022: THE CONSUMER CLAIMS THE CORD SPARKED ON THE DEVICE AND BURNED PART OF THE DEVICE WHERE IT ATTACHES. INJURIES DID NOT OCCUR AND THE CONSUMER ACCEPTED A REPLACEMENT. THEREFORE AN INVESTIGATION WILL NOT OCCUR.
Additional Manufacturer Narrative
12/13/2022 - THE CONSUMER ACCEPTED A REPLACEMENT PRODUCT AND WILL NOT BE RETURNING THE DEVICE FOR AN INVESTIGATION. 7/8/2023 - SUBMITTING A SUPPLEMENTAL EMDR TO THE FDA AS WE MISTAKENLY ENTERING THE INCORRECT MEDICAL DEVICE PROBLEM CODE. CHANGING THE MEDICAL DEVICE PROBLEM CODE "FAIL-SAFE PROBLEM TO "APPROPRIATE TERM / CODE NOT AVAILABLE.
Description of Event or Problem
12/13/2022 - THE CONSUMER CLAIMS THE PRODUCT SMELT LIKE IT WAS BURNT. THE CONSUMER ACCEPTED A REPLACEMENT AND WILL NOT BE RETURNING THE PRODUCT BACK TO THE MANUFACTURER FOR AN INVESTIGATION.