inforMED
MalfunctionJEQ

ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20RB

Received Jan 17, 2023

Report 3000302531-2023-00023 · MDR key 16183383

Device

Generic name

Toothbrush, Powered - Jeq

Model number

EB20RB

Lot number

4210201052708I

Product problems

  • No Apparent Adverse Event
  • Break
  • No Apparent Adverse Event

Patient

Unknown

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

Narrative

Additional Manufacturer Narrative

PRODUCT RETURN WAS REQUESTED BUT NOT RECEIVED SO FAR. FULL EVALUATION WILL OCCUR UPON RECEIPT OF RETURNED PRODUCT.

Description of Event or Problem

WONT CLICK ONTO THE BRUSH HOLDER...COME OFF - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THEIR ORAL-B TRIZONE TOOTHBRUSH HEADS WOULD NOT CLICK ONTO THE ORAL-B TOOTHBRUSH HOLDER AND CAME OFF WHILE BRUSHING. NO INJURY WAS REPORTED.

Description of Event or Problem

WONT CLICK ONTO THE BRUSH HOLDER...COME OFF - ORAL-B [DEVICE BREAKAGE]. PRODUCT COUNTERFEIT - ORAL-B [PRODUCT COUNTERFEIT]. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THEIR ORAL-B TRIZONE TOOTHBRUSH HEADS WOULD NOT CLICK ONTO THE ORAL-B TOOTHBRUSH HOLDER AND CAME OFF WHILE BRUSHING. NO INJURY WAS REPORTED. ON 08-FEB-2023: CASE UPDATE: THE SUSPECT PRODUCT LOT WAS 4210201052708I. NO INJURY WAS REPORTED. ON 02-MAR-2023: CASE UPDATE: THE SUSPECT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN EB20RB. NO INJURY WAS REPORTED. ON 16-MAR-2023: 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

ON 16-MAR-2023: PRODUCT INVESTIGATION RESULTS: PRODUCT WAS IDENTIFIED AS A NON-GENUINE ORAL-B PRODUCT, IT WAS NOT MANUFACTURED UNDER P&G CONTROL.