inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE4729

Received May 21, 2024

Report 3000302531-2024-00239 · MDR key 19359443

Device

Generic name

Toothbrush, Powered - Jeq

Model number

4729

Lot number

1BB20412227

Product problems

  • No Apparent Adverse Event
  • No Apparent Adverse Event

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

BRUSH HEAD...FALLS OFF - ORAL-B [DEVICE BREAKAGE]. BRUSH HEAD IS LOOSE - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE ORAL-B TOOTHBRUSH HEAD WAS LOOSE AND FELL OFF OF THE ORAL-B JUNIOR TOOTHBRUSH WHILE BRUSHING. NO INJURY WAS REPORTED. 09-MAY-2024 FOLLOW UP VIA PICTURES: THE CONCOMITANT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 4729. NO INJURY WAS REPORTED. 02-JUL-2024 CASE UPDATE: THE CONCOMITANT PRODUCT LOT WAS 1BB204122227. NO INJURY WAS REPORTED. 17-JUL-2024 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 02-JUL-2024: THE CONCOMITANT PRODUCT LOT WAS 1BB20412227. NO INJURY WAS REPORTED. 14-AUG-2024 PRODUCT INVESTIGATION RESULTS: THE SUSPECT PRODUCT WAS CONFIRMED TO BE ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 4729. THE CONCOMITANT PRODUCT WAS CONFIRMED TO BE ORAL-B POWER ORAL CARE REFILLS SENSITIVE CLEAN. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

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

Description of Event or Problem

BRUSH HEAD...FALLS OFF - ORAL-B [DEVICE BREAKAGE]. BRUSH HEAD IS LOOSE - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE ORAL-B TOOTHBRUSH HEAD WAS LOOSE AND FELL OFF OF THE ORAL-B JUNIOR TOOTHBRUSH WHILE BRUSHING. NO INJURY WAS REPORTED.