inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE4729JRJUNIOR

Received Mar 1, 2024

Report 3000302531-2024-00082 · MDR key 18818180

Device

Generic name

Toothbrush, Powered - Jeq

Model number

4729

Lot number

1BB23320716

Product problems

  • No Apparent Adverse Event
  • No Apparent Adverse Event

Patient

NA · Male

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

Narrative

Description of Event or Problem

WHITE THING ON THE FLOOR...THE BIT WHERE YOU¿VE GOT THE TOOTHBRUSH HEAD...HEAD ITS COMING OFF, IT WON¿T HOLD IN PLACE...WHITE CIRCULAR THING THAT HAS GONE ¿ THAT BIT HAS SOMEHOW FELL OFF - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: A FATHER VIA PHONE STATED THAT HE FOUND A WHITE THING ON THE FLOOR, WHICH ENDED UP BEING THE BIT ON THE ORAL-B TOOTHBRUSH, TYPE 4729, WHERE THE ORAL-B SENSITIVE TOOTHBRUSH HEAD WENT. THE ORAL-B SENSITIVE TOOTHBRUSH HEAD WAS COMING OFF AND WOULD NOT HOLD IN PLACE BECAUSE THE WHITE CIRCULAR THING THAT WAS GONE AND SOMEHOW FELL OFF. NO INJURY WAS REPORTED. 07-MAR-2024 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 05-MAR-2024: THE SUSPECT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN EB20. NO INJURY WAS REPORTED. 09-APR-2024 PRODUCT INVESTIGATION RESULTS: THE SUSPECT PRODUCT WAS CONFIRMED TO BE ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 4729 JUNIOR . THE CONCOMITANT PRODUCT WAS CONFIRMED TO BE ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN EB20. NO INJURY WAS REPORTED. 12-APR-2024 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 05-MAR-2024: THE CONCOMITANT PRODUCT LOT WAS U3250. NO INJURY WAS REPORTED. 12-APR-2024 AMENDMENT FROM INFORMATION INITIALLY RECEIVED ON 05-MAR-2024: THE CONCOMITANT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS SENSI ULTRATHIN EB60. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

09-APR-2024 PRODUCT INVESTIGATION RESULTS: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.

Description of Event or Problem

WHITE THING ON THE FLOOR...THE BIT WHERE YOU¿VE GOT THE TOOTHBRUSH HEAD...HEAD ITS COMING OFF, IT WON¿T HOLD IN PLACE...WHITE CIRCULAR THING THAT HAS GONE ¿ THAT BIT HAS SOMEHOW FELL OFF - ORAL-B [DEVICE BREAKAGE] . CASE NARRATIVE: A FATHER VIA PHONE STATED THAT HE FOUND A WHITE THING ON THE FLOOR, WHICH ENDED UP BEING THE BIT ON THE ORAL-B TOOTHBRUSH, TYPE 4729, WHERE THE ORAL-B SENSITIVE TOOTHBRUSH HEAD WENT. THE ORAL-B SENSITIVE TOOTHBRUSH HEAD WAS COMING OFF AND WOULD NOT HOLD IN PLACE BECAUSE THE WHITE CIRCULAR THING THAT WAS GONE AND SOMEHOW FELL OFF. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.