inforMED
MalfunctionEFS

PHILIPS SONICARE

Received May 17, 2024 · Event occurred May 8, 2024

Report 3026630-2024-00033 · MDR key 19341439

Device

Generic name

Yangtze Power Flosser

Catalog number

HX3811/20

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

THE EVENT DATE IS APPROXIMATE. PRODUCT WAS NOT RETURNED TO CONFIRM A MALFUNCTION HAS OCCURRED. H3 OTHER TEXT : PRODUCT NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

THE CONSUMER ALLEGED THAT THE POWER FLOSSER CHARGER EXPLODED. THERE WAS NO ALLEGATION OF INJURY OR PROPERTY DAMAGE. A POTENTIAL FIRE HAZARD WAS IDENTIFIED.

Description of Event or Problem

THIS CASE IS NOW DETERMINED TO BE NOT REPORTABLE. THE DEVICE WAS RETURNED FOR INVESTIGATION, AND IT WAS DETERMINED THAT THE CAUSE OF THE CUSTOMERS COMPLAINT IS CHEMICAL EXPOSURE DAMAGE OF THE POWER SUPPLY WALL ADAPTER NOT ORIGINATING FROM THE DEVICE ITSELF. THE CUSTOMER HAD NO INJURY REPORTED OR PROPERTY DAMAGE.

Additional Manufacturer Narrative

THIS CASE IS NOW DETERMINED TO BE NOT REPORTABLE. THE DEVICE WAS RETURNED FOR INVESTIGATION, AND IT WAS DETERMINED THAT THE CAUSE OF THE CUSTOMERS COMPLAINT IS CHEMICAL EXPOSURE DAMAGE OF THE POWER SUPPLY WALL ADAPTER NOT ORIGINATING FROM THE DEVICE ITSELF. THE CUSTOMER HAD NO INJURY REPORTED OR PROPERTY DAMAGE. REPORTABILITY FOR INITIAL MFR REPORT NUMBER 3026630-2024-00033 SUBMITTED ON 05/17/2024 CAN BE REMOVED.