inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3771GENIUSX

Received Mar 4, 2025

Report 3000302531-2025-00092 · MDR key 21517810

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3771

Lot number

BH13840738

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

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 FLIES OFF - ORAL-B [DEVICE BREAKAGE]. HEADS HAVE STARTED TO COME LOOSE FROM THE TOOTHBRUSH - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: MALE CONSUMER VIA E-MAIL REPORTED THAT THE ORAL-B PRO CROSS ACTION TOOTHBRUSH HEADS CAME LOOSE FROM THE ORAL-B TOOTHBRUSH HANDLE, TYPE 3771 AND THE HEAD FLEW OFF WHILE HE WAS BRUSHING HIS TEETH. NO INJURY WAS REPORTED. 10-FEB-2025 FOLLOW-UP VIA E-MAIL: THE CONCOMITANT PRODUCT LOT NUMBER WAS BH13840738. NO INJURY WAS REPORTED.

Description of Event or Problem

HEAD FLIES OFF - ORAL-B [DEVICE BREAKAGE]. HEADS HAVE STARTED TO COME LOOSE FROM THE TOOTHBRUSH - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: MALE CONSUMER VIA E-MAIL REPORTED THAT THE ORAL-B PRO CROSS ACTION TOOTHBRUSH HEADS CAME LOOSE FROM THE ORAL-B TOOTHBRUSH HANDLE, TYPE 3771 AND THE HEAD FLEW OFF WHILE HE WAS BRUSHING HIS TEETH. NO INJURY WAS REPORTED. 10-FEB-2025 FOLLOW-UP VIA E-MAIL: THE CONCOMITANT PRODUCT LOT NUMBER WAS BH13840738. NO INJURY WAS REPORTED. 17-APR-2025 PRODUCT INVESTIGATION RESULTS: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3771 GENIUS X. THE CONCOMITANT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS CROSSACTION. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

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