inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3756

Received Apr 29, 2025

Report 3000302531-2025-00170 · MDR key 21923905

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3756

Lot number

1AD84961600

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 ATTACHMENT KEEPS SLIPPING OFF OF THE HANDPIECE DURING USE [DEVICE CONNECTION ISSUE] TIP OF THE ATTACHMENT... GROUND DOWN [DEVICE PHYSICAL PROPERTY ISSUE]. CASE NARRATIVE: CONSUMER E-MAIL STATED THAT THE TIP OF THE ATTACHMENT HAS ALREADY BEEN GROUND DOWN AFTER A FEW MONTHS AND THE BRUSH ATTACHMENT KEEPS SLIPPING OFF OF THE HANDPIECE DURING USE, WHICH CAUSES AN UNSAFE USE. 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

10-JUL-2025: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.

Description of Event or Problem

BRUSH ATTACHMENT KEEPS SLIPPING OFF OF THE HANDPIECE DURING USE [DEVICE CONNECTION ISSUE]. TIP OF THE ATTACHMENT: GROUND DOWN [DEVICE PHYSICAL PROPERTY ISSUE]. CASE NARRATIVE: CONSUMER E-MAIL STATED THAT THE TIP OF THE ATTACHMENT HAS ALREADY BEEN GROUND DOWN AFTER A FEW MONTHS AND THE BRUSH ATTACHMENT KEEPS SLIPPING OFF OF THE HANDPIECE DURING USE, WHICH CAUSES AN UNSAFE USE. NO INJURY WAS REPORTED. 01-JUL-2025; CONCOMITANT PRODUCT UPDATED. FOLLOW-UP: (PRODUCT INVESTIGATION RESULTS). SUSPECT PRODUCT ORAL-B (HANDLE) AND CONCOMITANT PRODUCT (REFILLS) INVESTIGATED. FOR HANDLE, CAUSE OF FAILURE WAS CONSUMER RELATED - USAGE OF ABRASIVE TOOTHPASTE FOR LONG TIME CAUSES EXTREME WEAR AT METAL AND LOOSENING OF REFILL. FOR REFILLS, CAUSE OF FAILURE WAS CONSUMER RELATED - DAMAGED INSIDES OF REFILL TUBES DUE TO FIXATION ON A WORN SHARP DRIVING SHAFT. BASED ON INVESTIGATION RESULTS, NO MANUFACTURING CAUSE AND NO DESIGN ISSUE WAS IDENTIFIED. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

10-JUL-2025: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.

Description of Event or Problem

BRUSH ATTACHMENT KEEPS SLIPPING OFF OF THE HANDPIECE DURING USE [DEVICE CONNECTION ISSUE] TIP OF THE ATTACHMENT... GROUND DOWN [DEVICE PHYSICAL PROPERTY ISSUE]. CASE NARRATIVE: CONSUMER E-MAIL STATED THAT THE TIP OF THE ATTACHMENT HAS ALREADY BEEN GROUND DOWN AFTER A FEW MONTHS AND THE BRUSH ATTACHMENT KEEPS SLIPPING OFF OF THE HANDPIECE DURING USE, WHICH CAUSES AN UNSAFE USE. NO INJURY WAS REPORTED. 01-JUL-2025; CONCOMITANT PRODUCT UPDATED. FOLLOW-UP: (PRODUCT INVESTIGATION RESULTS) SUSPECT PRODUCT ORAL-B (HANDLE) AND CONCOMITANT PRODUCT (REFILLS) INVESTIGATED. FOR HANDLE, CAUSE OF FAILURE WAS CONSUMER RELATED - USAGE OF ABRASIVE TOOTHPASTE FOR LONG TIME CAUSES EXTREME WEAR AT METAL AND LOOSENING OF REFILL. FOR REFILLS, CAUSE OF FAILURE WAS CONSUMER RELATED - DAMAGED INSIDES OF REFILL TUBES DUE TO FIXATION ON A WORN SHARP DRIVING SHAFT. BASED ON INVESTIGATION RESULTS, NO MANUFACTURING CAUSE AND NO DESIGN ISSUE WAS IDENTIFIED. NO INJURY WAS REPORTED.