inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3766

Received Feb 11, 2025

Report 3000302531-2025-00054 · MDR key 21360709

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3766

Lot number

2CB83732131

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

Description of Event or Problem

BRUSH COMES OF THE SHAFT...DOESN'T STAY IN PLACE - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE ORAL-B TOOTHBRUSH HEAD CAME OFF THE ORAL-B TOOTHBRUSH SHAFT AND DID NOT STAY IN PLACE. NO INJURY WAS REPORTED. ON (B)(6) 2025, FOLLOW UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE CONSUMER WAS A 51-YEAR-OLD FEMALE. SHE DID NOT VISIT A HEALTHCARE PROVIDER. NO INJURY WAS REPORTED. ON (B)(6) 2025, FOLLOW UP VIA EMAIL: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3766. NO INJURY WAS REPORTED. ON (B)(6) 2025, FOLLOW UP VIA EMAIL: THE SUSPECT PRODUCT LOT WAS 2CB83732131. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

ON 26-MAR-2025, PRODUCT INVESTIGATION RESULTS: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.

Description of Event or Problem

BRUSH COMES OF THE SHAFT...DOESN'T STAY IN PLACE - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE ORAL-B TOOTHBRUSH HEAD CAME OFF THE ORAL-B TOOTHBRUSH SHAFT AND DID NOT STAY IN PLACE. NO INJURY WAS REPORTED. 23-JAN-2025 FOLLOW UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE CONSUMER WAS A 51-YEAR-OLD FEMALE. SHE DID NOT VISIT A HEALTHCARE PROVIDER. NO INJURY WAS REPORTED. 23-JAN-2025 FOLLOW UP VIA EMAIL: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3766. NO INJURY WAS REPORTED. 28-JAN-2025 FOLLOW UP VIA EMAIL: THE SUSPECT PRODUCT LOT WAS 2CB83732131. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

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