inforMED
MalfunctionJEQ

ORALBPWRORALCARERFLSDUALACTNEB417

Received Jan 31, 2025

Report 3000302531-2025-00039 · MDR key 21282115

Device

Generic name

Toothbrush, Powered - Jeq

Model number

EB417

Lot number

80343184

Product problems

  • No Apparent Adverse Event
  • No Apparent Adverse Event

Patient

NA · Male

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

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

BOTTOM PART OF THE TOOTHBRUSH HEAD WAS COMING LOOSE (OFF) IN MOUTH, ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: ELDERLY MALE CONSUMER REPORTED VIA PHONE THAT THE BOTTOM PART OF THE ORAL-B TOOTHBRUSH HEAD CAME LOOSE IN HIS MOUTH. NO INJURY WAS REPORTED. 18-JAN-2025 FOLLOW UP VIA PICTURE: THE SUSPECT PRODUCT LOT WAS 80343184. NO INJURY WAS REPORTED.

Description of Event or Problem

BOTTOM PART OF THE TOOTHBRUSH HEAD WAS COMING LOOSE (OFF) IN MOUTH - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: ELDERLY MALE CONSUMER REPORTED VIA PHONE THAT THE BOTTOM PART OF THE ORAL-B TOOTHBRUSH HEAD CAME LOOSE IN HIS MOUTH. NO INJURY WAS REPORTED. 18-JAN-2025 FOLLOW UP VIA PICTURE: THE SUSPECT PRODUCT LOT WAS 80343184. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

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