inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3710

Received Mar 26, 2025

Report 3000302531-2025-00118 · MDR key 21697332

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3710

Lot number

1RF41231005

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

76 YR · Male

  • Hemorrhage/Blood Loss/Bleeding
  • Hemorrhage/Blood Loss/Bleeding

Narrative

Description of Event or Problem

BLEEDING MOUTH [MOUTH HAEMORRHAGE] . OLD HEAD WAS TOUGH TO GET OFF AND WHEN IT DID COME OFF SOME PIECES CAME OFF - ORAL-B [DEVICE BREAKAGE] . REFILL HEAD IS LOOSE - ORAL-B [DEVICE CONNECTION ISSUE] . CASE NARRATIVE: 76-YEAR-OLD MALE CONSUMER VIA PHONE STATED THAT WHEN HE WAS CHANGING HIS OLD TOOTHBRUSH HEAD, IT WAS TOUGH TO GET OFF AND WHEN IT DID COME OFF SOME PIECES CAME OFF. NOW THE ORAL-B TOOTHBRUSH REFILL HEAD WAS LOOSE ON THE ORAL-B TOOTHBRUSH. HIS MOUTH BLED A LITTLE BIT. NO SERIOUS INJURY WAS REPORTED. 03-APR-2025 CASE UPDATE FROM INFORMATION INITIALLY LEARNED ON 19-MAR-2025: THE CONCOMITANT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3710. NO SERIOUS INJURY WAS REPORTED. 30-APR-2025 PRODUCT INVESTIGATION RESULTS: THE SUSPECT PRODUCT WAS CONFIRMED TO BE ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3710. THE CONCOMITANT PRODUCT WAS CONFIRMED TO BE ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN EB20 BRUSH SET 2CT. NO SERIOUS INJURY WAS REPORTED.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.

Description of Event or Problem

BLEEDING MOUTH [MOUTH HAEMORRHAGE]. OLD HEAD WAS TOUGH TO GET OFF AND WHEN IT DID COME OFF SOME PIECES CAME OFF - ORAL-B [DEVICE BREAKAGE]. REFILL HEAD IS LOOSE - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: 76-YEAR-OLD MALE CONSUMER VIA PHONE STATED THAT WHEN HE WAS CHANGING HIS OLD TOOTHBRUSH HEAD, IT WAS TOUGH TO GET OFF AND WHEN IT DID COME OFF SOME PIECES CAME OFF. NOW THE ORAL-B TOOTHBRUSH REFILL HEAD WAS LOOSE ON THE ORAL-B TOOTHBRUSH. HIS MOUTH BLED A LITTLE BIT. NO SERIOUS INJURY WAS REPORTED.