inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3756

Received Apr 4, 2025

Report 3000302531-2025-00151 · MDR key 21772832

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3756

Lot number

2CB84032344

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

NA · Male

  • Hemorrhage/Blood Loss/Bleeding
  • Pain
  • Unspecified Tissue Injury
  • Hemorrhage/Blood Loss/Bleeding
  • Pain
  • Unspecified Tissue Injury

Narrative

Description of Event or Problem

BLEEDING - GUM [GINGIVAL BLEEDING]. STABBED - GUM [GINGIVAL INJURY]. PAIN - GUM [GINGIVAL PAIN]. TOOTHBRUSH HEADS KEEPS COMING OFF - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: WIFE REPORTED VIA E-MAIL THAT HER HUSBAND¿S ORAL-B TOOTHBRUSH HEADS CAME OFF OF THE ORAL-B TOOTHBRUSH HANDLE WHILE HE CLEANED HIS TEETH AND STABBED HIS GUM WHICH CAUSED BLEEDING AND PAIN. 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

BLEEDING - GUM [GINGIVAL BLEEDING]. STABBED - GUM [GINGIVAL INJURY]. PAIN - GUM [GINGIVAL PAIN]. TOOTHBRUSH HEADS KEEPS COMING OFF - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: WIFE REPORTED VIA E-MAIL THAT HER HUSBAND¿S ORAL-B TOOTHBRUSH HEADS CAME OFF OF THE ORAL-B TOOTHBRUSH HANDLE WHILE HE CLEANED HIS TEETH AND STABBED HIS GUM WHICH CAUSED BLEEDING AND PAIN. NO SERIOUS INJURY WAS REPORTED. 15-MAY-2025 CASE UPDATE: THE SUSPECT PRODUCT LOT NUMBER WAS 2CB84032344. NO SERIOUS INJURY WAS REPORTED. 02-JUN-2025 CASE UPDATE FROM INFORMATION INITIALLY LEARNED ON 15-MAY-2025: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3756. NO SERIOUS INJURY WAS REPORTED.

Additional Manufacturer Narrative

ON 01-JUL-2025 PRODUCT INVESTIGATION RESULTS: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.