inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3764

Received Jun 4, 2024

Report 3000302531-2024-00262 · MDR key 19460123

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3764

Lot number

R44451722

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 RETURNED.

Description of Event or Problem

HEAD KEEPS COMING OFF - ORAL-B [DEVICE BREAKAGE] METAL PIN LOOKS FLATTER - ORAL-B [DEVICE PHYSICAL PROPERTY ISSUE]. CASE NARRATIVE: MALE CONSUMER VIA PHONE STATED THAT THE ORAL-B TOOTHBRUSH HEAD KEPT COMING OFF OF THE ORAL-B TRIUMPH TOOTHBRUSH. THE METAL PIN ALSO LOOKED FLATTER. NO INJURY WAS REPORTED. 13-MAY-2024 FOLLOW UP VIA PICTURES: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3764. THE SUSPECT PRODUCT LOT WAS R44451722. NO INJURY WAS REPORTED.

Description of Event or Problem

HEAD KEEPS COMING OFF - ORAL-B [DEVICE BREAKAGE] METAL PIN LOOKS FLATTER - ORAL-B [DEVICE PHYSICAL PROPERTY ISSUE] CASE NARRATIVE: MALE CONSUMER VIA PHONE STATED THAT THE ORAL-B TOOTHBRUSH HEAD KEPT COMING OFF OF THE ORAL-B TRIUMPH TOOTHBRUSH. THE METAL PIN ALSO LOOKED FLATTER. NO INJURY WAS REPORTED. 13-MAY-2024 FOLLOW UP VIA PICTURES: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3764. THE SUSPECT PRODUCT LOT WAS R44451722. NO INJURY WAS REPORTED. 26-JUL-2024 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 24-JUL-2024: THE CONCOMITANT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN EB20. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

06-SEP-2024 PRODUCT INVESTIGATION RESULTS: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.