inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3756

Received Oct 2, 2024

Report 3000302531-2024-00466 · MDR key 20350128

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3756

Lot number

F51441345

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

62 YR · Male

  • Laceration(s)
  • Ulcer
  • Choking
  • Foreign Body In Patient
  • Unspecified Tissue Injury
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
  • Upper Respiratory Tract Injury
  • Laceration(s)
  • Ulcer
  • Choking
  • Foreign Body In Patient
  • Unspecified Tissue Injury
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
  • Upper Respiratory Tract Injury

Narrative

Description of Event or Problem

CHOKING [CHOKING], NEARLY CHOKE [CHOKING SENSATION], CUT / ROOF OF MOUTH/SCRATCHES TO ROOF OF MOUTH [MOUTH INJURY], CUT ON LEFT HAND SIDE OF TONGUE [TONGUE INJURY], SCRATCHES IN THROAT [PHARYNGEAL INJURY], ULCERS ("ALCERS") IN MOUTH ON SIDE OF TONGUE [MOUTH ULCERATION], BRUSH HEAD FELL DOWN THROAT [FOREIGN BODY IN THROAT], HEAD TO SLIDE OFF - ORAL-B [DEVICE BREAKAGE], CLIP THAT HOLDS THE HEAD IN PLACE NO LONGER FUNCTIONS PROPERLY - ORAL-B [DEVICE PHYSICAL PROPERTY ISSUE]. CASE NARRATIVE: CONSUMER VIA PHONE STATED THAT THE CLIP HOLDING THE ORAL-B TOOTHBRUSH HEAD IN PLACE NO LONGER FUNCTIONED PROPERLY, CAUSING THE IT TO SLIDE OFF OF THE ORAL-B TOOTHBRUSH. THE ORAL-B TOOTHBRUSH HEAD FELL DOWN THEIR THROAT, CAUSING THEM TO NEARLY CHOKE AND RESULTING IN SCRATCHES IN THEIR THROAT. NO SERIOUS INJURY WAS REPORTED. 16-SEP-2024: FOLLOW UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE CONSUMER WAS A 62-YEAR-OLD MALE. HE EXPERIENCED CHOKING, SCRATCHES TO THE ROOF OF HIS MOUTH, AND CUTS ON THE LEFT-HAND SIDE OF HIS TONGUE AND ON THE ROOF OF HIS MOUTH. NO SERIOUS INJURY WAS REPORTED. 21-SEP-2024: FOLLOW UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE CONSUMER REPORTED EXPERIENCING THE FOLLOWING ADDITIONAL ADVERSE EVENT: ULCERS ("ALCERS") IN HIS MOUTH ON THE SIDE OF HIS TONGUE. NO SERIOUS INJURY WAS REPORTED. 11-OCT-2024: FOLLOW UP VIA PICTURES: THE ORAL-B TOOTHBRUSH HEAD CAME OFF IN HIS MOUTH WHILE HE WAS BRUSHING THE BACK OF HIS TONGUE. THE SUSPECT PRODUCT LOT WAS F51441345. NO SERIOUS INJURY WAS REPORTED.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

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

Description of Event or Problem

CHOKING [CHOKING]. NEARLY CHOKE [CHOKING SENSATION]. CUT ROOF OF MOUTH/SCRATCHES TO ROOF OF MOUTH [MOUTH INJURY]. CUT ON LEFT HAND SIDE OF TONGUE [TONGUE INJURY]. SCRATCHES IN THROAT [PHARYNGEAL INJURY]. ULCERS ("ALCERS") IN MOUTH ON SIDE OF TONGUE [MOUTH ULCERATION]. BRUSH HEAD FELL DOWN THROAT [FOREIGN BODY IN THROAT] HEAD TO SLIDE OFF - ORAL-B [DEVICE BREAKAGE]. CLIP THAT HOLDS THE HEAD IN PLACE NO LONGER FUNCTIONS PROPERLY - ORAL-B [DEVICE PHYSICAL PROPERTY ISSUE]. CASE NARRATIVE: CONSUMER VIA PHONE STATED THAT THE CLIP HOLDING THE ORAL-B TOOTHBRUSH HEAD IN PLACE NO LONGER FUNCTIONED PROPERLY, CAUSING THE IT TO SLIDE OFF OF THE ORAL-B TOOTHBRUSH. THE ORAL-B TOOTHBRUSH HEAD FELL DOWN THEIR THROAT, CAUSING THEM TO NEARLY CHOKE AND RESULTING IN SCRATCHES IN THEIR THROAT. NO SERIOUS INJURY WAS REPORTED. (B)(6) 2024 FOLLOW UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE CONSUMER WAS A 62-YEAR-OLD MALE. HE EXPERIENCED CHOKING, SCRATCHES TO THE ROOF OF HIS MOUTH, AND CUTS ON THE LEFT-HAND SIDE OF HIS TONGUE AND ON THE ROOF OF HIS MOUTH. NO SERIOUS INJURY WAS REPORTED. (B)(6) 2024 FOLLOW UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE CONSUMER REPORTED EXPERIENCING THE FOLLOWING ADDITIONAL ADVERSE EVENT: ULCERS ("ALCERS") IN HIS MOUTH ON THE SIDE OF HIS TONGUE. NO SERIOUS INJURY WAS REPORTED.