inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3765SMART

Received Jul 25, 2025

Report 3000302531-2025-00344 · MDR key 22607312

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3765

Lot number

BC206020550

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

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 IS COMING OFF INSIDE MOUTH... METAL SECTION THAT ENGAGES INTO THE BRUSH HEAD SEEMS BROKEN OFF HALFWAY DOWN - ORAL-B TOOTHBRUSH [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER E-MAIL STATED THAT THE METAL SECTION THAT ENGAGES INTO THE BRUSH HEAD SEEMS TO HAVE POSSIBLY BROKEN OFF HALFWAY DOWN. ALSO, THE BRUSH HEAD IS COMING OFF INSIDE MOUTH. NO INJURY WAS REPORTED. FOLLOW UP: CONCOMITANT PRODUCT UPDATED.

Description of Event or Problem

BRUSH HEAD IS COMING OFF INSIDE MOUTH... METAL SECTION THAT ENGAGES INTO THE BRUSH HEAD SEEMS BROKEN OFF HALFWAY DOWN; ORAL-B TOOTHBRUSH [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER E-MAIL STATED THAT THE METAL SECTION THAT ENGAGES INTO THE BRUSH HEAD SEEMS TO HAVE POSSIBLY BROKEN OFF HALFWAY DOWN. ALSO, THE BRUSH HEAD IS COMING OFF INSIDE MOUTH. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

24-SEP-2025 PRODUCT INVESTIGATIONS RESULTS: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.

Description of Event or Problem

BRUSH HEAD IS COMING OFF INSIDE MOUTH... METAL SECTION THAT ENGAGES INTO THE BRUSH HEAD SEEMS BROKEN OFF HALFWAY DOWN - ORAL-B TOOTHBRUSH [DEVICE BREAKAGE] . CASE NARRATIVE: CONSUMER E-MAIL STATED THAT THE METAL SECTION THAT ENGAGES INTO THE BRUSH HEAD SEEMS TO HAVE POSSIBLY BROKEN OFF HALFWAY DOWN. ALSO, THE BRUSH HEAD IS COMING OFF INSIDE MOUTH. NO INJURY WAS REPORTED. FOLLOW UP: CONCOMITANT PRODUCT UPDATED. FOLLOW-UP: BATCH/LOT NO. DELETED FOR CONCOMITANT PRODUCT. FOLLOW-UP: PRODUCT INVESTIGATION RESULT: 24-SEP-2025: NO MANUFACTURING CAUSE AND NO DESIGN ISSUE IDENTIFIED BASED ON INVESTIGATION.

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 IS COMING OFF INSIDE MOUTH. METAL SECTION THAT ENGAGES INTO THE BRUSH HEAD SEEMS BROKEN OFF HALFWAY DOWN - ORAL-B TOOTHBRUSH [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER E-MAIL STATED THAT THE METAL SECTION THAT ENGAGES INTO THE BRUSH HEAD SEEMS TO HAVE POSSIBLY BROKEN OFF HALFWAY DOWN. ALSO, THE BRUSH HEAD IS COMING OFF INSIDE MOUTH. NO INJURY WAS REPORTED. FOLLOW UP: CONCOMITANT PRODUCT UPDATED. FOLLOW-UP: BATCH/LOT NO. DELETED FOR CONCOMITANT PRODUCT.