PHILIPS SONICARE
Report
- Report Number
- 3026630-2024-00025
- Event Type
- Malfunction
- Date Received
- May 13, 2024
- Date of Event
- April 9, 2024
- Report Date
- June 25, 2024
- Manufacturer
- PHILIPS ORAL HEALTHCARE, LLC
- Product Code
- EFS
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
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).
THE EVENT DATE IS APPROXIMATE. PRODUCT WAS NOT RETURNED TO CONFIRM A MALFUNCTION HAS OCCURRED.
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).
THE CONSUMER REPORTED THAT THE YANGTZE POWER FLOSSER IS GETTING HOT AND LOOKS BURNED DOWN. A POTENTIAL SAFETY HAZARD WAS IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 450361 | PHILIPS SONICARE | YANGTZE POWER FLOSSER | EFS | PHILIPS ORAL HEALTHCARE, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |