inforMED
MalfunctionJEQ

ORALBPWRORALCARERFLSDUALACTNEB417BRUSHSET3CT

Received May 15, 2025

Report 3000302531-2025-00203 · MDR key 22025628

Device

Generic name

Toothbrush, Powered - Jeq

Model number

EB417

Lot number

91574239

Product problems

  • No Apparent Adverse Event
  • No Apparent Adverse Event

Patient

80 YR · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

BOTTOM PART OF THE BRUSH HEAD BROKE OFF INTO MOUTH - ORAL-B [DEVICE BREAKAGE] . CASE NARRATIVE: CONSUMER VIA PHONE STATED THAT WHILE BRUSHING HER TEETH, BOTTOM PART OF THE BRUSH HEAD BROKE OFF INTO HER MOUTH. SHE DIDN'T CHOKE OR GOT HURT. NO INJURY WAS REPORTED. FOLLOW-UP: PRODUCT RETURN WAS RECEIVED AND EVALUATED. 'NO MANUFACTURING CAUSE' AND 'NO DESIGN ISSUE' IDENTIFIED BASED ON INVESTIGATION.

Additional Manufacturer Narrative

30-JUN-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

BOTTOM PART OF THE BRUSH HEAD BROKE OFF INTO MOUTH - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA PHONE STATED THAT WHILE BRUSHING HER TEETH, BOTTOM PART OF THE BRUSH HEAD BROKE OFF INTO HER MOUTH. SHE DIDN'T CHOKE OR GOT HURT. NO INJURY WAS REPORTED.