inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3771

Received Dec 20, 2024

Report 3000302531-2024-00634 · MDR key 20995688

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3771

Lot number

BH13350204

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

NA · Unknown

  • Unspecified Tissue Injury
  • Unspecified Tissue Injury

Narrative

Additional Manufacturer Narrative

19-FEB-2025 PRODUCT INVESTIGATION RESULTS: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.

Description of Event or Problem

INJURED GUMS [GINGIVAL INJURY], INJURED LIPS [LIP INJURY] , BRUSH HEAD REGULARLY SLIPPED DOWN - ORAL-B [DEVICE BREAKAGE] , ATTACHMENT THAT CAME LOOSE...NO MORE SECURE HOLD - ORAL-B [DEVICE CONNECTION ISSUE], LOCKING MECHANISM, WHICH HOLDS THE ATTACHMENT ON THE WIRE PIN OF THE ELECTRIC TOOTHBRUSH, WAS WORN OUT - ORAL-B [DEVICE PHYSICAL PROPERTY ISSUE] . CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE ORAL-B TOOTHBRUSH'S LOCKING MECHANISM HOLDING THE ORAL-B TOOTHBRUSH HEAD ATTACHMENT ON THE WIRE PIN OF THE ELECTRIC TOOTHBRUSH WAS WORN OUT, SUCH THAT THE BRUSH HEAD REGULARLY SLIPPED DOWN. THE ORAL-B TOOTHBRUSH HEAD ATTACHMENT CAME LOOSE AND DID NOT HAVE A SECURE HOLD. THEY INJURED THEIR GUMS AND LIPS. NO SERIOUS INJURY WAS REPORTED. 07-JAN-2025 CASE UPDATE: THE SUSPECT PRODUCT LOT WAS BH13350204. NO SERIOUS INJURY WAS REPORTED. 28-JAN-2025 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 07-JAN-2025: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3771. 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

INJURED GUMS [GINGIVAL INJURY], INJURED LIPS [LIP INJURY], BRUSH HEAD REGULARLY SLIPPED DOWN - ORAL-B [DEVICE BREAKAGE], ATTACHMENT THAT CAME LOOSE, NO MORE SECURE HOLD - ORAL-B [DEVICE CONNECTION ISSUE], LOCKING MECHANISM, WHICH HOLDS THE ATTACHMENT ON THE WIRE PIN OF THE ELECTRIC TOOTHBRUSH, WAS WORN OUT - ORAL-B [DEVICE PHYSICAL PROPERTY ISSUE]. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE ORAL-B TOOTHBRUSH'S LOCKING MECHANISM HOLDING THE ORAL-B TOOTHBRUSH HEAD ATTACHMENT ON THE WIRE PIN OF THE ELECTRIC TOOTHBRUSH WAS WORN OUT, SUCH THAT THE BRUSH HEAD REGULARLY SLIPPED DOWN. THE ORAL-B TOOTHBRUSH HEAD ATTACHMENT CAME LOOSE AND DID NOT HAVE A SECURE HOLD. THEY INJURED THEIR GUMS AND LIPS. NO SERIOUS INJURY WAS REPORTED.