inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3710PROVITALITY

Received Dec 13, 2024

Report 3000302531-2024-00619 · MDR key 20928612

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3710

Lot number

1UF21712349

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

46 YR · Male

  • Red Eye(s)
  • Eye Pain
  • Eye Irritation
  • Red Eye(s)
  • Eye Pain
  • Eye Irritation

Narrative

Description of Event or Problem

PAIN - EYE [EYE PAIN]. BURNING EYES [EYE IRRITATION]. EYES BRIGHT RED, BLOOD SHOT [OCULAR HYPERAEMIA]. EXPLODED IN FACE - ORAL-B [DEVICE EXPULSION]. SIGNS OF RUST INSIDE THE TOOTHBRUSH - ORAL-B [DEVICE PHYSICAL PROPERTY ISSUE]. CASE NARRATIVE: MALE CONSUMER VIA E-MAIL STATED THAT THE ORAL-B TOOTHBRUSH EXPLODED IN HIS FACE THIS MORNING WHILE HE WAS BRUSHING HIS TEETH AND THERE WERE SIGNS OF RUST INSIDE THE TOOTHBRUSH. HE WAS GOING TO A&E TO GET HIS EYES CHECKED OUT. NO SERIOUS INJURY WAS REPORTED. (B)(6) 2024 FOLLOW UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE 46 YEAR OLD MALE CONSUMER EXPERIENCED EYE PAIN, BURNING EYES, AND BRIGHT RED/BLOOD SHOT EYES. NO SERIOUS INJURY WAS REPORTED.

Additional Manufacturer Narrative

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

Description of Event or Problem

PAIN - EYE [EYE PAIN]. BURNING EYES [EYE IRRITATION]. EYES BRIGHT RED, BLOOD SHOT [OCULAR HYPERAEMIA]. EXPLODED IN FACE - ORAL-B [DEVICE EXPULSION]. SIGNS OF RUST INSIDE THE TOOTHBRUSH - ORAL-B [DEVICE PHYSICAL PROPERTY ISSUE]. CASE NARRATIVE: MALE CONSUMER VIA E-MAIL STATED THAT THE ORAL-B TOOTHBRUSH EXPLODED IN HIS FACE THIS MORNING WHILE HE WAS BRUSHING HIS TEETH AND THERE WERE SIGNS OF RUST INSIDE THE TOOTHBRUSH. HE WAS GOING TO A&E TO GET HIS EYES CHECKED OUT. NO SERIOUS INJURY WAS REPORTED. 28-NOV-2024 FOLLOW UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE 46-YEAR-OLD MALE CONSUMER EXPERIENCED EYE PAIN, BURNING EYES, AND BRIGHT RED/BLOOD SHOT EYES. NO SERIOUS INJURY WAS REPORTED. 17-DEC-2024 CASE UPDATE: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3710 PRO VITALITY. THE SUSPECT PRODUCT LOT WAS 1UF21712349. NO SERIOUS INJURY WAS REPORTED.

Additional Manufacturer Narrative

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