inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE4729

Received Feb 21, 2024

Report 3000302531-2024-00078 · MDR key 18747451

Device

Generic name

Toothbrush, Powered - Jeq

Model number

4729

Lot number

1BB22521113

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

HEAD ON ELECTRIC TOOTHBRUSH...SLIPS OFF - ORAL-B [DEVICE BREAKAGE]. HEAD ON ELECTRIC TOOTHBRUSH IS VERY LOOSE - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: A PARENT VIA E-MAIL REPORTED THAT THE ORAL-B TOOTHBRUSH HEAD WAS VERY LOOSE ON THEIR SON'S ORAL-B ELECTRIC TOOTHBRUSH AND SLIPPED OFF WHEN HE WAS BRUSHING HIS TEETH. NO INJURY WAS REPORTED. 08-FEB-2024 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 30-JAN-2024: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 4729. NO INJURY WAS REPORTED. 04-APR-2024 CASE UPDATE: THE SUSPECT PRODUCT LOT WAS 1BB22521113. THE CONCOMITANT PRODUCT LOT WAS P310. NO INJURY WAS REPORTED. 05-APR-2024 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 04-APR-2024: THE CONCOMITANT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS SENSI ULTRATHIN EB60. NO INJURY WAS REPORTED. 23-APR-2024 AMENDMENT FROM INFORMATION INITIALLY RECEIVED ON 04-APR-2024: THE CONCOMITANT PRODUCT LOT (P310) WAS DELETED. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

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

Description of Event or Problem

HEAD ON ELECTRIC TOOTHBRUSH...SLIPS OFF - ORAL-B [DEVICE BREAKAGE]. HEAD ON ELECTRIC TOOTHBRUSH IS VERY LOOSE - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: A PARENT VIA E-MAIL REPORTED THAT THE ORAL-B TOOTHBRUSH HEAD WAS VERY LOOSE ON THEIR SON'S ORAL-B ELECTRIC TOOTHBRUSH AND SLIPPED OFF WHEN HE WAS BRUSHING HIS TEETH. NO INJURY WAS REPORTED. 08-FEB-2024 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 30-JAN-2024: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 4729. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

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