inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3756

Received Oct 2, 2024

Report 3000302531-2024-00465 · MDR key 20350143

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3756

Lot number

1AD01641051

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

65 YR · Male

  • Unspecified Tissue Injury
  • Unspecified Tissue Injury

Narrative

Description of Event or Problem

PINCHED LIP / BITE - LIPS [LIP INJURY]. PINCHED LIP / BITE - GUMS [GINGIVAL INJURY]. BRUSH HEAD WOULD ALSO COME OFF OF THE TOOTHBRUSH HANDLE SHAFT AND INTO MY MOUTH / HEAD WAS LOOSE IN MY MOUTH - ORAL-B [DEVICE BREAKAGE]. BRUSH HEAD IS ABOUT 1/8 OF A INCH RAISED / DOES NOT SIT FLUSH ON THE TOOTHBRUSH HANDLES SHAFT / WIGGLE A LOT ON THE TOOTHBRUSH HANDLE SHAFT AREA - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: 65-YEAR-OLD MALE CONSUMER REPORTED VIA PHONE THAT THE ORAL-B TOOTHBRUSH HEADS BIT AND PINCHED HIS GUMS AND LIPS WHEN THEY CAME OFF OF THE ORAL-B TOOTHBRUSH HANDLE, TYPE 3756 AND INTO HIS MOUTH. THEY WERE LOOSE IN HIS MOUTH, ABOUT 1/8 OF AN INCH RAISED OFF OF THE TOOTHBRUSH HANDLE AND DID NOT SIT FLUSH, WIGGLING ON THE TOOTHBRUSH HANDLE SHAFT. NO SERIOUS 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

PINCHED LIP / BITE - LIPS [LIP INJURY] . PINCHED LIP / BITE - GUMS [GINGIVAL INJURY] . BRUSH HEAD WOULD ALSO COME OFF OF THE TOOTHBRUSH HANDLE SHAFT AND INTO MY MOUTH / HEAD WAS LOOSE IN MY MOUTH - ORAL-B [DEVICE BREAKAGE] . BRUSH HEAD IS ABOUT 1/8 OF A INCH RAISED / DOES NOT SIT FLUSH ON THE TOOTHBRUSH HANDLES SHAFT / WIGGLE A LOT ON THE TOOTHBRUSH HANDLE SHAFT AREA - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: 65-YEAR-OLD MALE CONSUMER REPORTED VIA PHONE THAT THE ORAL-B TOOTHBRUSH HEADS BIT AND PINCHED HIS GUMS AND LIPS WHEN THEY CAME OFF OF THE ORAL-B TOOTHBRUSH HANDLE, TYPE 3756 AND INTO HIS MOUTH. THEY WERE LOOSE IN HIS MOUTH, ABOUT 1/8 OF AN INCH RAISED OFF OF THE TOOTHBRUSH HANDLE AND DID NOT SIT FLUSH, WIGGLING ON THE TOOTHBRUSH HANDLE SHAFT. NO SERIOUS INJURY WAS REPORTED. 16-OCT-2024 AMENDMENT FROM INFORMATION INITIALLY RECEIVED ON 24-SEP-2024: THE CONCOMITANT PRODUCT ORAL-B POWER ORAL CARE REFILLS LOT (1AD01641051) WAS DELETED. NO INJURY WAS REPORTED. 17-OCT-2024 AMENDMENT FROM INFORMATION INITIALLY RECEIVED ON 24-SEP-2024: THE CONCOMITANT PRODUCT ORAL-B POWER ORAL CARE REFILLS LOT WAS 1AD01641051. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

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