inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3771GENIUSX

Received Dec 1, 2025

Report 3000302531-2025-00537 · MDR key 23677589

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3771

Lot number

BH20932100

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

64 YR · Male

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

Narrative

Additional Manufacturer Narrative

24 SEPTEMBER 2025 PRODUCT INVESTIGATION RESULT: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.

Description of Event or Problem

TONGUE INJURY [TONGUE INJURY]. LIPS INJURING...SCRATCH IN THE UPPER LEFT LIP [LIP INJURY]. WOUND [WOUND]. BRUSH HEADS COME LOOSE FROM THE TOOTHBRUSH - ORAL-B [DEVICE CONNECTION ISSUE]. BRUSH HEAD HOLDER METAL PIN IS WORN OUT - ORAL-B TOOTHBRUSH [DEVICE PHYSICAL PROPERTY ISSUE]. BRUSH HEADS FALL OFF. SUDDENLY ENDS UP IN MOUTH - ORAL-B TOOTHBRUSH [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA EMAIL STATED THAT METAL HAS BECOME WORN DOWN, CAUSING THE BRUSH HEADS TO FALL OFF THAT INJURED LIPS AND TONGUE WITH THE ROTATING HOLDING PIN. NO SERIOUS INJURY WAS REPORTED. FOLLOW UP (24-SEP-2025). COMPLAINED PRODUCT WAS RECEIVED AND PRODUCT INVESTIGATION RESULTS INDICATED THAT USER HANDLING WAS THE ROOT CAUSE OF THE COMPLAINT. CONCLUSION CODE: NO MANUFACTURING CAUSE AND NO DESIGN ISSUE IDENTIFIED BASED ON INVESTIGATION. (B)(6) 2026, CORRECTION PERFORMED TO THE DATA RECEIVED ON (B)(6) 2025: THE INITIAL RECEIPT DATE FOR THE CASE IS (B)(6) 2025 INSTEAD OF (B)(6) 2025.

Additional Manufacturer Narrative

24 SEPTEMBER 2025. PRODUCT INVESTIGATION RESULT: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.

Description of Event or Problem

TONGUE INJURY [TONGUE INJURY]. LIPS INJURING...SCRATCH IN THE UPPER LEFT LIP [LIP INJURY]. WOUND [WOUND]. BRUSH HEADS COME LOOSE FROM THE TOOTHBRUSH - ORAL-B [DEVICE CONNECTION ISSUE]. BRUSH HEAD HOLDER METAL PIN IS WORN OUT - ORAL-B TOOTHBRUSH [DEVICE PHYSICAL PROPERTY ISSUE]. BRUSH HEADS FALL OFF...SUDDENLY ENDS UP IN MOUTH - ORAL-B TOOTHBRUSH [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA EMAIL STATED THAT METAL HAS BECOME WORN DOWN, CAUSING THE BRUSH HEADS TO FALL OFF THAT INJURED LIPS AND TONGUE WITH THE ROTATING HOLDING PIN. NO SERIOUS INJURY WAS REPORTED. FOLLOW UP (24-SEP-2025) COMPLAINED PRODUCT WAS RECEIVED AND PRODUCT INVESTIGATION RESULTS INDICATED THAT USER HANDLING WAS THE ROOT CAUSE OF THE COMPLAINT. CONCLUSION CODE: NO MANUFACTURING CAUSE AND NO DESIGN ISSUE IDENTIFIED BASED ON INVESTIGATION.