inforMED
MalfunctionJEQ

ORALBPWRORALCARERFLSDUALACTNEB417BRUSHSET3CT

Received Mar 11, 2025

Report 3000302531-2025-00101 · MDR key 21572455

Device

Generic name

Toothbrush, Powered - Jeq

Model number

EB417

Lot number

91508172

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

NA · Female

  • Laceration(s)
  • Laceration(s)

Narrative

Description of Event or Problem

CUT LIP [LIP INJURY]. BOTTOM CLUSTER OF BRUSHES BROKE OFF THE REFILL - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: A SPOUSE VIA PHONE REPORTED THAT THEIR WIFE (FEMALE) CUT HER LIP WHEN THE BOTTOM CLUSTER OF BRUSHES BROKE OFF THE ORAL-B TOOTHBRUSH HEAD REFILL. 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

ON 21-MAY-2025, PRODUCT INVESTIGATION RESULTS: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.

Description of Event or Problem

CUT LIP [LIP INJURY]. BOTTOM CLUSTER OF BRUSHES BROKE OFF THE REFILL - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: A SPOUSE VIA PHONE REPORTED THAT THEIR WIFE (FEMALE) CUT HER LIP WHEN THE BOTTOM CLUSTER OF BRUSHES BROKE OFF THE ORAL-B TOOTHBRUSH HEAD REFILL. NO SERIOUS INJURY WAS REPORTED.