inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3765GENIUS

Received Sep 24, 2025

Report 3000302531-2025-00434 · MDR key 23130783

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3765

Lot number

BC906120013

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

NA · Female

  • Unspecified Tissue Injury
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
  • Unspecified Tissue Injury
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Additional Manufacturer Narrative

11-SEP-2025: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.

Description of Event or Problem

INJURED MY LIP [LIP INJURY], LIP BLED [LIP HAEMORRHAGE], BRUSH HEADS COME LOOSE WHILE BRUSHING [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: CONSUMER STATED ON PHONE THAT BRUSH HEAD CAME LOOSE WHILE BRUSHING, IT INJURED THEIR LIP AND LIP BLED. NO SERIOUS INJURY WAS REPORTED. 03-JUL-2025: DEVICE INFORMATION UPDATED ON DATA RECEIVED ON 02-JUL-2025. FOLLOW-UP: SUSPECT PRODUCT UPDATED. FOLLOW-UP (PRODUCT INVESTIGATION RESULTS): SUSPECT PRODUCT UPDATED ON BASIS OF PRODUCT INVESTIGATION RESULTS. PRODUCT INVESTIGATION RESULT FOR ORAL-B REFILLS (CONCOMITANT) AND ORAL-B TOOTHBRUSH HANDLE (SUSPECT) WERE RECEIVED. THE RECEIVED REFILL WAS ORIGINAL AND CAN BE FIXED PROPERLY ON SAMPLE HANDLE BUT NOT ON RECEIVED HANDLE. NO TECHNICAL FAILURE FOUND IN RECEIVED REFILL. THE DRIVING SHAFT OF ORAL-B TOOTHBRUSH (HANDLE) WAS WORN AND ABRADED. CAUSE OF FAILURE WAS CONSUMER RELATED (USAGE OF ABRASIVE TOOTHPASTE FOR LONG TIME CAUSED EXTREME WEAR AT METAL AND LOOSENING REFILL). BASED ON INVESTIGATION "NO MANUFACTURING CAUSE" AND "NO DESIGN ISSUE" WAS IDENTIFIED. NO SERIOUS INJURY WAS REPORTED.