inforMED
MalfunctionJEQ

ORALBPWRORALCARERFLS

Received Feb 26, 2025

Report 3000302531-2025-00085 · MDR key 21471454

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3708

Lot number

BUA33460427

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

54 YR · Male

  • Pain
  • Unspecified Tissue Injury
  • Pain
  • Unspecified Tissue Injury

Narrative

Additional Manufacturer Narrative

15-APR-2025 PRODUCT INVESTIGATION RESULTS: PRODUCT RETURN WAS RECEIVED AND IDENTIFIED AS A NON-GENUINE ORAL-B PRODUCT, IT WAS NOT MANUFACTURED UNDER P&G CONTROL.

Description of Event or Problem

IMPALED / STABBED FACE - SKIN [SKIN INJURY], PAIN - FACE- SKIN [PAIN OF SKIN] , BRUSH HEAD HAS COME OFF THE BODY - ORAL-B [DEVICE BREAKAGE], HEAD BECOMES LOOSE - ORAL-B [DEVICE CONNECTION ISSUE], PRODUCT COUNTERFEIT - ORAL-B [PRODUCT COUNTERFEIT]. CASE NARRATIVE: MALE CONSUMER VIA E-MAIL REPORTED THAT THE ORAL-B TOOTHBRUSH HEADS WERE LOOSE AND CAME OFF OF THE ORAL-B TOOTHBRUSH HANDLE WHILE HE WAS BRUSHING HIS TEETH AND IMPALED HIM IN THE FACE. NO SERIOUS INJURY WAS REPORTED. ON (B)(6) 2025 FOLLOW-UP VIA IMAGE: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3708. NO SERIOUS INJURY WAS REPORTED. ON (B)(6) 2025 FOLLOW-UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE CONSUMER WAS 54 YEARS OLD. NO MEDICAL PROFESSIONAL WAS CONTACTED. THE CONSUMER ALSO EXPERIENCED PAIN IN HIS FACE WITH A WORSENING OF HIS SYMPTOMS. NO SERIOUS INJURY WAS REPORTED. 13-MAR-2025 CASE UPDATE: THE SUSPECT PRODUCT LOT WAS 3UA33460427. NO SERIOUS INJURY WAS REPORTED. 15-APR-2025 PRODUCT INVESTIGATION RESULTS: THE SUSPECT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS. THE CONCOMITANT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3708. THE SUSPECT PRODUCT INVOLVED WAS CONFIRMED TO BE A COUNTERFEIT, SO THE PRODUCT PROBLEM WILL BE REMOVED FROM THE ORAL-B TOOTHBRUSH HEAD REFILL. NO SERIOUS INJURY WAS REPORTED.

Description of Event or Problem

IMPALED / STABBED FACE - SKIN [SKIN INJURY]. PAIN - FACE- SKIN [PAIN OF SKIN] . BRUSH HEAD HAS COME OFF THE BODY - ORAL-B [DEVICE BREAKAGE]. HEAD BECOMES LOOSE - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: MALE CONSUMER VIA E-MAIL REPORTED THAT THE ORAL-B TOOTHBRUSH HEADS WERE LOOSE AND CAME OFF OF THE ORAL-B TOOTHBRUSH HANDLE WHILE HE WAS BRUSHING HIS TEETH AND IMPALED HIM IN THE FACE. NO SERIOUS INJURY WAS REPORTED. 07-FEB-2025 FOLLOW-UP VIA IMAGE: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3708. NO SERIOUS INJURY WAS REPORTED. 07-FEB-2025 FOLLOW-UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE CONSUMER WAS 54 YEARS OLD. NO MEDICAL PROFESSIONAL WAS CONTACTED. THE CONSUMER ALSO EXPERIENCED PAIN IN HIS FACE WITH A WORSENING OF HIS SYMPTOMS. NO SERIOUS INJURY WAS REPORTED.

Additional Manufacturer Narrative

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