inforMED
MalfunctionJEQ

ORALBPWRORALCARERFLSKIDSEB10SBRUSHSET4CT

Received May 13, 2025

Report 3000302531-2025-00204 · MDR key 22010977

Device

Generic name

Toothbrush, Powered - Jeq

Model number

EB10S

Lot number

4051B21100

Product problems

  • No Apparent Adverse Event
  • No Apparent Adverse Event

Patient

5 YR · Male

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

Narrative

Additional Manufacturer Narrative

1-JUL-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.

Description of Event or Problem

TOP OF THE HEAD CAME OFF/ BRISTLES CAME OUT OF ONE OF THE PARTS OF THE HEAD- ORAL-B POWER TOOTHBRUSH [DEVICE BREAKAGE]. PRODUCT COUNTERFEIT- ORAL-B. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE LATEST ORAL-B PRO KIDS ELECTRIC TOOTHBRUSH HEADS HE PURCHASED FOR HIS SON; TOP OF THE HEAD CAME OFF THE FIRST ONE AND THE SECOND ONE- THE BRISTLES CAME OUT OF ONE OF THE PARTS OF THE HEAD. NO INJURY WAS REPORTED. 1-JUL-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

PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.

Description of Event or Problem

TOP OF THE HEAD CAME OFF/ BRISTLES CAME OUT OF ONE OF THE PARTS OF THE HEAD- ORAL-B POWER TOOTHBRUSH [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE LATEST ORAL-B PRO KIDS ELECTRIC TOOTHBRUSH HEADS HE PURCHASED FOR HIS SON; TOP OF THE HEAD CAME OFF THE FIRST ONE AND THE SECOND ONE- THE BRISTLES CAME OUT OF ONE OF THE PARTS OF THE HEAD. NO INJURY WAS REPORTED.

Description of Event or Problem

TOP OF THE HEAD CAME OFF/BRISTLES CAME OUT OF ONE OF THE PARTS OF THE HEAD- ORAL-B POWER TOOTHBRUSH [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE LATEST ORAL-B PRO KIDS ELECTRIC TOOTHBRUSH HEADS HE PURCHASED FOR HIS SON; TOP OF THE HEAD CAME OFF THE FIRST ONE AND THE SECOND ONE- THE BRISTLES CAME OUT OF ONE OF THE PARTS OF THE HEAD. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.