inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3771GENIUSX

Received May 16, 2025

Report 3000302531-2025-00215 · MDR key 22034115

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3771

Lot number

BH41431454

Product problems

  • No Apparent Adverse Event
  • No Apparent Adverse Event

Patient

NA · Male

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

Narrative

Description of Event or Problem

BRUSH HEAD ITSELF STARTED TO ROTATE WHEN USING - ORAL-B [DEVICE PHYSICAL PROPERTY ISSUE] BRUSH HEAD COMES LOOSE IN THE MOUTH - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA PHONE STATED THAT WHILE BRUSHING HIS TEETH, BRUSH HEAD ITSELF STARTED TO ROTATE, AND IT COMES LOOSE IN 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

ON 22-JUL-2025: PRODUCT INVESTIGATION RESULTS: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.

Description of Event or Problem

BRUSH HEAD ITSELF STARTED TO ROTATE WHEN USING - ORAL-B [DEVICE PHYSICAL PROPERTY ISSUE] BRUSH HEAD COMES LOOSE IN THE MOUTH - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA PHONE STATED THAT WHILE BRUSHING HIS TEETH, BRUSH HEAD ITSELF STARTED TO ROTATE, AND IT COMES LOOSE IN MOUTH. NO INJURY WAS REPORTED. 22-JUL-2025 PRODUCT INVESTIGATION RESULTS: THE PRODUCT WAS RECEIVED BY THE MANUFACTURER ON 03-JUN-2025. NO MANUFACTURING CAUSE AND NO DESIGN ISSUE IDENTIFIED BASED ON INVESTIGATION. NO INJURY WAS REPORTED.