inforMED
MalfunctionEFS

PHILIPS SONICARE

Received Feb 7, 2024 · Event occurred Jan 26, 2024

Report 3026630-2024-00008 · MDR key 18664388

Device

Generic name

Power Flosser 3000 Hx3806/33 Cordless Water Flosser With Accessories

Catalog number

HX3806/33

Product problems

  • Break
  • Material Fragmentation
  • Break
  • Material Fragmentation

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THIS CASE IS NOW DETERMINED TO BE NOT REPORTABLE. REPORTABILITY FOR INITIAL MFR REPORT NUMBER 5E6E8B34-C605-11EE-84DD-000032A67E77@HPP SUBMITTED ON FEBRUARY 07, 2024 CAN BE REMOVED.

Description of Event or Problem

THIS CASE IS NOW DETERMINED TO BE NOT REPORTABLE. REPORTABILITY FOR INITIAL MFR REPORT NUMBER 5E6E8B34-C605-11EE-84DD-000032A67E77@HPP SUBMITTED ON FEBRUARY 07, 2024 CAN BE REMOVED.

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

IT WAS REPORTED THAT THE NOZZLE BROKE IN THE CUSTOMER'S MOUTH. THE BREAK CAUSED SMALL PARTS THAT COULD POSE A CHOKING HAZARD. THE CUSTOMER DID NOT REPORT AN INJURY.