inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3771GENIUSXGENIUSX

Received Aug 5, 2025

Report 3000302531-2025-00335 · MDR key 22714077

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3771

Lot number

BH94361100

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

Additional Manufacturer Narrative

COMPLAINED PRODUCT RECEIVED: USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.

Description of Event or Problem

[ORAL-B REFILLS] DOES NOT STAY ON THE TOOTHBRUSH AND COMES OFF [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER E-MAIL STATED TOOTHBRUSH HEADS DOES NOT STAY ON THE TOOTHBRUSH AND COMES OFF DURING BRUSHING. NO INJURY WAS REPORTED. ON 07-07-2025: (PRODUCT INVESTIGATION RESULTS) PRODUCT INVESTIGATION RESULTS STATED THAT SUSPECT PRODUCT IS ORAL-B TOOTHBRUSH (HANDLE). ORAL-B TOOTHBRUSH (HANDLE) INVESTIGATED, RECEIVED HANDLE HAS WORN AND ABRADED METAL SHAFT AND DOME, DUE TO WHICH THE SAMPLE REFILL CANNOT RELIABLY ATTACH ON THE HANDLE. NO MANUFACTURING CAUSE AND NO DESIGN ISSUE IDENTIFIED FOR HANDLE. NO INJURY WAS REPORTED.