inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3756

Received Mar 12, 2025

Report 3000302531-2025-00108 · MDR key 21582099

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3756

Lot number

F53632324

Product problems

  • No Apparent Adverse Event
  • No Apparent Adverse Event

Patient

54 YR · Female

  • 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

HEAD FELL IN MY MOUTH / REFILL HEAD IS HANGING OUT OF MY MOUTH IN MY MOUTH [DEVICE BREAKAGE]. REFILL HEADS ARE LOOSE - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: 54-YEAR-OLD FEMALE CONSUMER REPORTED VIA PHONE THAT THE ORAL-B TOOTHBRUSH HEAD WAS LOOSE AND FELL IN HER MOUTH. NO INJURY WAS REPORTED. 02-MAR-2025 FOLLOW-UP VIA IMAGE: THE SUSPECT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS SENSITIVE EBS17 BRUSH SET. THE SUSPECT PRODUCT LOT NUMBER WAS REMOVED. NO INJURY WAS REPORTED.

Description of Event or Problem

HEAD [...] FELL IN MY MOUTH / REFILL HEAD IS HANGING OUT OF MY MOUTH IN MY MOUTH [DEVICE BREAKAGE]. REFILL HEADS ARE LOOSE - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: 54-YEAR-OLD FEMALE CONSUMER REPORTED VIA PHONE THAT THE ORAL-B TOOTHBRUSH HEAD WAS LOOSE AND FELL IN HER MOUTH. NO INJURY WAS REPORTED. 02-MAR-2025 FOLLOW-UP VIA IMAGE: THE SUSPECT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS SENSITIVE EBS17 BRUSH SET. THE SUSPECT PRODUCT LOT NUMBER WAS REMOVED. NO INJURY WAS REPORTED. 11-APR-2025 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 03-APR-2025: THE SUSPECT PRODUCT LOT NUMBER WAS 43098335R0. THE CONCOMITANT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3756. NO INJURY WAS REPORTED. 29-APR-2025 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 03-APR-2025: THE CONCOMITANT PRODUCT LOT NUMBER WAS F53632324. NO INJURY WAS REPORTED. 21-MAY-2025 PRODUCT INVESTIGATION RESULTS: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3756. THE CONCOMITANT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS SENSITIVE EBS17 BRUSH SET. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

21-MAY-2025 PRODUCT INVESTIGATION RESULTS: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.