inforMED
MalfunctionJEQ

ORALBPWRORALCARERFLSCROSSACTNEB50RXBRUSHSET4CT

Received Nov 19, 2025

Report 3000302531-2025-00528 · MDR key 23592013

Device

Generic name

Toothbrush, Powered - Jeq

Model number

EB50RX

Lot number

1047786000

Product problems

  • No Apparent Adverse Event
  • No Apparent Adverse Event

Patient

51 YR · Female

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

Narrative

Additional Manufacturer Narrative

PRODUCT RETURN WAS NOT RECEIVED. PRODUCT RETURN WAS REQUESTED. FULL EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.

Description of Event or Problem

METAL PARTS CAME OFF IN MOUTH AND HEAD FELL APART¿ DISC CAME OFF AND THE INTERNAL BUILT OF A METAL CAME OUT ¿ ORAL-B REFILLS [DEVICE BREAKAGE]. WASN'T PAIN OR ANY OTHER SYMPTOMS [NO ADVERSE EVENT]. CASE NARRATIVE: CONSUMER CALLED VIA PHONE STATING THAT WHILE BRUSHING THE METAL PARTS OF CROSS ACTION BRUSH HEAD CAME OFF IN MOUTH AND BRUSH HEAD FELL APART. THE DISC CAME OFF FROM THE BRISTLES PART AND THE INTERNAL BUILT OF A METAL CAME OUT. NO INJURY WAS REPORTED.

Description of Event or Problem

METAL PARTS CAME OFF IN MOUTH AND HEAD FELL APART¿ DISC CAME OFF AND THE INTERNAL BUILT OF A METAL CAME OUT ¿ ORAL-B REFILLS [DEVICE BREAKAGE]. PRODUCT COUNTERFEIT-ORAL-B REFILLS [PRODUCT COUNTERFEIT]. CASE NARRATIVE: CONSUMER CALLED VIA PHONE STATING THAT WHILE BRUSHING THE METAL PARTS OF CROSS ACTION BRUSH HEAD CAME OFF IN MOUTH AND BRUSH HEAD FELL APART. THE DISC CAME OFF FROM THE BRISTLES PART AND THE INTERNAL BUILT OF A METAL CAME OUT. NO INJURY WAS REPORTED. FOLLOW-UP: 17-DEC-2025-PRODUCT INVESTIGATION RESULTS-THE PRODUCT INVOLVED WAS CONFIRMED TO BE A COUNTERFEIT, SO THE PRODUCT PROBLEM WILL BE REMOVED FROM THE ORAL-B TOOTHBRUSH HEAD REFILL. NO INJURY WAS REPORTED

Additional Manufacturer Narrative

17-DEC-2025: PRODUCT INVESTIGATION RESULTS-PRODUCT RETURN WAS RECEIVED AND IDENTIFIED AS A NON-GENUINE ORAL-B PRODUCT, IT WAS NOT MANUFACTURED UNDER P&G CONTROL.