inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3756

Received Oct 16, 2024

Report 3000302531-2024-00497 · MDR key 20459949

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3756

Lot number

1 AB 113 20659

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

62 YR · Male

  • Hemorrhage/Blood Loss/Bleeding
  • Unspecified Tissue Injury
  • Hemorrhage/Blood Loss/Bleeding
  • Unspecified Tissue Injury

Narrative

Additional Manufacturer Narrative

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

Description of Event or Problem

BLOOD - SKIN [SKIN HAEMORRHAGE]. JABS IN THE FACE/INJURY - SKIN [SKIN INJURY]. TOOTHBRUSH HEAD COMES OFF - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: MALE CONSUMER VIA E-MAIL STATED THAT WHILE BRUSHING HIS TEETH, THE ORAL-B TOOTHBRUSH HEAD CAME OFF AND THE SPINNING, METAL PIN JABBED HIM IN THE FACE, DRAWING BLOOD. NO SERIOUS INJURY WAS REPORTED. 03-OCT-2024 FOLLOW UP VIA E-MAIL: THE SUSPECT PRODUCT LOT WAS 1 AB 113 20659. THE MALFUNCTION ALSO HAPPENED WITH PREVIOUS ORAL-B TOOTHBRUSH HEADS. NO SERIOUS INJURY WAS REPORTED. 03-OCT-2024 FOLLOW UP VIA PICTURES: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3756. THE CONCOMITANT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS CROSSACTION EB50. NO SERIOUS INJURY WAS REPORTED. 07-OCT-2024 FOLLOW UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE 62 YEAR OLD MALE CONSUMER REPORTED THAT HE CLEANED THE AREA AS TREATMENT, ESPECIALLY WHEN THE INJURY DREW BLOOD. NO SERIOUS INJURY WAS REPORTED.

Description of Event or Problem

BLOOD - SKIN [SKIN HAEMORRHAGE]. JABS IN THE FACE/INJURY - SKIN [SKIN INJURY] TOOTHBRUSH HEAD COMES OFF - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: MALE CONSUMER VIA E-MAIL STATED THAT WHILE BRUSHING HIS TEETH, THE ORAL-B TOOTHBRUSH HEAD CAME OFF AND THE SPINNING, METAL PIN JABBED HIM IN THE FACE, DRAWING BLOOD. NO SERIOUS INJURY WAS REPORTED. 03-OCT-2024 FOLLOW UP VIA E-MAIL: THE SUSPECT PRODUCT LOT WAS 1 AB 113 20659. THE MALFUNCTION ALSO HAPPENED WITH PREVIOUS ORAL-B TOOTHBRUSH HEADS. NO SERIOUS INJURY WAS REPORTED. 03-OCT-2024 FOLLOW UP VIA PICTURES: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3756. THE CONCOMITANT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS CROSSACTION EB50. NO SERIOUS INJURY WAS REPORTED. 07-OCT-2024 FOLLOW UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE 62-YEAR-OLD MALE CONSUMER REPORTED THAT HE CLEANED THE AREA AS TREATMENT, ESPECIALLY WHEN THE INJURY DREW BLOOD. NO SERIOUS INJURY WAS REPORTED.

Additional Manufacturer Narrative

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