ORALBRCHGTOOTHBRUSHHANDLE3764
Received Jun 12, 2025
Report 3000302531-2025-00269 · MDR key 22193467
Device
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
ORIGINAL BRUSH HEADS NO LONGER FIT ON TOOTHBRUSH¿BRUSH HEADS ARE LOOSE¿SLIDE DOWN DURING USE [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: CONSUMER EMAIL STATED THAT THE ORIGINAL BRUSH HEADS NO LONGER FIT ON TOOTHBRUSH. THE BRUSH HEADS ARE LOOSE AND THEY SLIDE DOWN DURING USE. NO INJURY WAS REPORTED. FOLLOW UP: CONCOMITANT PRODUCT UPDATED. FOLLOW-UP: (PRODUCT INVESTIGATION RESULTS): AN INVESTIGATION WAS PERFORMED FOR THE ORAL-B TOOTHBRUSH (SUSPECTED) AND ORAL-B REFILLS (CONCOMITANT). THE ORAL-B TOOTHBRUSH HAD THE APPEARANCE OF A BREAKAGE; THE SURFACE WAS BRITTLE AND SHARP-EDGED. THE CAUSE OF FAILURE WAS CONSUMER RELATED. THE ORAL-B REFILLS WERE ALL ORIGINALLY PACKED (STILL SEALED) IN BLISTERS AND COULD BE RELIABLY ATTACHED TO A SAMPLE HANDLE. NO TECHNICAL FAILURE WAS FOUND FOR THE REFILLS. NO MANUFACTURING CAUSE OR DESIGN ISSUE WAS IDENTIFIED BASED ON THE INVESTIGATION. NO SERIOUS INJURY WAS REPORTED.
Additional Manufacturer Narrative
23-OCT-2025: 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
ORIGINAL BRUSH HEADS NO LONGER FIT ON TOOTHBRUSH¿BRUSH HEADS ARE LOOSE¿SLIDE DOWN DURING USE [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: CONSUMER EMAIL STATED THAT THE ORIGINAL BRUSH HEADS NO LONGER FIT ON TOOTHBRUSH. THE BRUSH HEADS ARE LOOSE AND THEY SLIDE DOWN DURING USE. NO INJURY WAS REPORTED.
Description of Event or Problem
ORIGINAL BRUSH HEADS NO LONGER FIT ON TOOTHBRUSH¿BRUSH HEADS ARE LOOSE¿SLIDE DOWN DURING USE [DEVICE CONNECTION ISSUE] CASE NARRATIVE: CONSUMER EMAIL STATED THAT THE ORIGINAL BRUSH HEADS NO LONGER FIT ON TOOTHBRUSH. THE BRUSH HEADS ARE LOOSE AND THEY SLIDE DOWN DURING USE. NO INJURY WAS REPORTED. FOLLOW UP: CONCOMITANT PRODUCT UPDATED.
Additional Manufacturer Narrative
PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.