PHILIPS SONICARE
Received May 13, 2024 · Event occurred Apr 9, 2024
Report 3026630-2024-00025 · MDR key 19297410
Device
Product problems
- Overheating of Device
- Overheating of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ON (B)(6) 2024, PHILIPS ORAL HEALTH CARE DETERMINED THAT THE ALLEGATION OF GETTING HOT AND LOOKS BURNED DOWN IS NOT LIKELY TO CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO REOCCUR. THESE CASES ARE NOW DETERMINED TO BE NOT REPORTABLE. THE RESIDUAL RISK EVALUATED IN RMM D000578795 (PID_4A) RELATED TO (MELTING OR BURNT APPEARANCE), CONSIDERS FOR THE S3 (SERIOUS INJURY) POH <1 PPB (IMPROBABLE/NOT EXPECTED TO OCCUR) AND FOR S4 (DEATH) POH IS<1 PPB (IMPROBABLE/NOT EXPECTED TO OCCUR).
Description of Event or Problem
ON (B)(6) 2024, PHILIPS ORAL HEALTH CARE DETERMINED THAT THE ALLEGATION OF GETTING HOT AND LOOKS BURNED DOWN IS NOT LIKELY TO CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO REOCCUR. THESE CASES ARE NOW DETERMINED TO BE NOT REPORTABLE. THE RESIDUAL RISK EVALUATED IN RMM D000578795 (PID_4A) RELATED TO (MELTING OR BURNT APPEARANCE), CONSIDERS FOR THE S3 (SERIOUS INJURY) POH <1 PPB (IMPROBABLE/NOT EXPECTED TO OCCUR) AND FOR S4 (DEATH) POH IS<1 PPB (IMPROBABLE/NOT EXPECTED TO OCCUR).
Additional Manufacturer Narrative
THE EVENT DATE IS APPROXIMATE. PRODUCT WAS NOT RETURNED TO CONFIRM A MALFUNCTION HAS OCCURRED.
Description of Event or Problem
THE CONSUMER REPORTED THAT THE YANGTZE POWER FLOSSER IS GETTING HOT AND LOOKS BURNED DOWN. A POTENTIAL SAFETY HAZARD WAS IDENTIFIED.