inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3764PRO7000

Received May 14, 2024

Report 3000302531-2024-00233 · MDR key 19309968

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3764

Lot number

R94631207

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

46 YR · Male

  • Bruise/Contusion
  • Hemorrhage/Blood Loss/Bleeding
  • Pain
  • Unspecified Tissue Injury
  • Bruise/Contusion
  • Hemorrhage/Blood Loss/Bleeding
  • Pain
  • Unspecified Tissue Injury

Narrative

Description of Event or Problem

SCRATCHED THE INSIDE OF CHEEK, GUMS, AND LIP...LOTS OF BLEEDING [MOUTH HAEMORRHAGE] PAIN LOWER GUMS, LEFT [GINGIVAL PAIN] PAIN LOWER LIPS, LEFT [LIP PAIN] TOOTHACHE FRONT TEETH [TOOTHACHE] SCRATCHED THE INSIDE OF CHEEK [MOUTH INJURY] SCRATCHED THE INSIDE OF GUMS [GINGIVAL INJURY] SCRATCHED THE INSIDE OF LIP [LIP INJURY] CHEEK IS BRUISED [ORAL CONTUSION] BRUSH HEAD FELL OF...MISSING A PART - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: 46 YEAR OLD MALE CONSUMER VIA PHONE STATED THAT THE ORAL-B TOOTHBRUSH HEAD FELL OFF AND THEN THE ORAL-B TOOTHBRUSH SCRATCHED THE INSIDE OF HIS CHEEK, GUMS, AND LIP. THERE WAS LOTS OF BLEEDING AND PAIN/IT HURT. HIS CHEEK WAS BRUISED AND HE HAD A TOOTHACHE. THE ORAL-B TOOTHBRUSH LOOKS LIKE IT WAS MISSING A PART. NO SERIOUS INJURY WAS REPORTED.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

30-SEP-2024 PRODUCT INVESTIGATION RESULTS: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.

Description of Event or Problem

SCRATCHED THE INSIDE OF CHEEK, GUMS, AND LIP...LOTS OF BLEEDING [MOUTH HAEMORRHAGE]. PAIN LOWER GUMS, LEFT [GINGIVAL PAIN]. PAIN LOWER LIPS, LEFT [LIP PAIN]. TOOTHACHE FRONT TEETH [TOOTHACHE]. SCRATCHED THE INSIDE OF CHEEK [MOUTH INJURY]. SCRATCHED THE INSIDE OF GUMS [GINGIVAL INJURY]. SCRATCHED THE INSIDE OF LIP [LIP INJURY]. CHEEK IS BRUISED [ORAL CONTUSION]. BRUSH HEAD FELL OF...MISSING A PART - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: 46-YEAR-OLD MALE CONSUMER VIA PHONE STATED THAT THE ORAL-B TOOTHBRUSH HEAD FELL OFF AND THEN THE ORAL-B TOOTHBRUSH SCRATCHED THE INSIDE OF HIS CHEEK, GUMS, AND LIP. THERE WAS LOTS OF BLEEDING AND PAIN/IT HURT. HIS CHEEK WAS BRUISED AND HE HAD A TOOTHACHE. THE ORAL-B TOOTHBRUSH LOOKS LIKE IT WAS MISSING A PART. NO SERIOUS INJURY WAS REPORTED. 10-SEP-2024 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 22-AUG-2024: THE SUSPECT PRODUCT LOT WAS (B)(4). NO SERIOUS INJURY WAS REPORTED.