inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3772PRO33000MODELD505.513.3

Received Jul 24, 2024

Report 3000302531-2024-00355 · MDR key 19815599

Device

Generic name

Toothbrush, Powered - Jeq

Model number

D505.513.3

Lot number

3DB32711217

Product problems

  • No Apparent Adverse Event
  • No Apparent Adverse Event

Patient

41 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

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

Description of Event or Problem

TOP PART OF THE METAL HANDLE CAME LOOSE INSIDE THE BRUSH HEAD/5 MM OF THE METAL PIN HAS COME OFF - ORAL-B [DEVICE BREAKAGE]. BRUSH HEAD ISN'T ATTACHED AND SLIDES UP - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE TOP METAL PART OF THE ORAL-B TOOTHBRUSH HANDLE CAME LOOSE INSIDE THE ORAL-B TOOTHBRUSH HEAD WHILE THEY BRUSHED THEIR TEETH. THE ORAL-B TOOTHBRUSH HEAD WASN'T ATTACHED AND SLID UP ON THE ORAL-B TOOTHBRUSH HANDLE. NO INJURY WAS REPORTED. 04-JUL-2024 FOLLOW UP VIA E-MAIL: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3772 PRO 3 3000 MODEL D505.513.3. THE SUSPECT PRODUCT LOT WAS 3DB32711217. NO INJURY WAS REPORTED. 09-JUL-2024 FOLLOW UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE CONSUMER WAS A 41 YEAR OLD MALE. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

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

Description of Event or Problem

TOP PART OF THE METAL HANDLE CAME LOOSE INSIDE THE BRUSH HEAD/5 MM OF THE METAL PIN HAS COME OFF - ORAL-B [DEVICE BREAKAGE] . BRUSH HEAD ISN'T ATTACHED AND SLIDES UP - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE TOP METAL PART OF THE ORAL-B TOOTHBRUSH HANDLE CAME LOOSE INSIDE THE ORAL-B TOOTHBRUSH HEAD WHILE THEY BRUSHED THEIR TEETH. THE ORAL-B TOOTHBRUSH HEAD WASN'T ATTACHED AND SLID UP ON THE ORAL-B TOOTHBRUSH HANDLE. NO INJURY WAS REPORTED. 04-JUL-2024 FOLLOW UP VIA E-MAIL: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3772 PRO 3 3000 MODEL D505.513.3. THE SUSPECT PRODUCT LOT WAS 3DB32711217. NO INJURY WAS REPORTED. 09-JUL-2024 FOLLOW UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE CONSUMER WAS A 41 YEAR OLD MALE. NO INJURY WAS REPORTED. 05-AUG-2024 CASE UPDATE: THE CONCOMITANT PRODUCT LOT WAS N3203. NO INJURY WAS REPORTED.