inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3764

Received Mar 21, 2024

Report 3000302531-2024-00131 · MDR key 18949259

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3764

Lot number

R83612158

Product problems

  • No Apparent Adverse Event
  • No Apparent Adverse Event

Patient

77 YR · Male

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

Narrative

Description of Event or Problem

ORIGINAL BRUSH HEADS...COME OFF - ORAL-B [DEVICE BREAKAGE]. ORIGINAL BRUSH HEADS...SNAP INTO PLACE VERY WEAKLY, I.E., THEY SIT VERY LOOSELY ON THE HAND PIECE - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE ORIGINAL ORAL-B TOOTHBRUSH HEADS SNAPPED INTO PLACE VERY WEAKLY AND SAT VERY LOOSELY ON THE ORAL-B TOOTHBRUSH HAND PIECE. THEY THEN CAME OFF MID-BRUSHING. NO INJURY WAS REPORTED. 10-MAR-2024 FOLLOW UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE CONSUMER WAS A 77 YEAR OLD MALE. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

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

Description of Event or Problem

ORIGINAL BRUSH HEADS...COME OFF - ORAL-B [DEVICE BREAKAGE]. ORIGINAL BRUSH HEADS...SNAP INTO PLACE VERY WEAKLY, I.E., THEY SIT VERY LOOSELY ON THE HAND PIECE - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE ORIGINAL ORAL-B TOOTHBRUSH HEADS SNAPPED INTO PLACE VERY WEAKLY AND SAT VERY LOOSELY ON THE ORAL-B TOOTHBRUSH HAND PIECE. THEY THEN CAME OFF MID-BRUSHING. NO INJURY WAS REPORTED. 10-MAR-2024 FOLLOW UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE CONSUMER WAS A 77 YEAR OLD MALE. NO INJURY WAS REPORTED. 22-MAR-2024 FOLLOW UP VIA PICTURES: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3764. THE CONCOMITANT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS SENSI ULTRATHIN EB60. NO INJURY WAS REPORTED. 28-MAR-2024 CASE UPDATE: THE SUSPECT PRODUCT LOT WAS R83612158. THE CONCOMITANT PRODUCT LOT WAS X2140. NO INJURY WAS REPORTED. 25-APR-2024 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 28-MAR-2024: A SECOND CONCOMITANT PRODUCT WAS ORAL-B POWER POWER ORAL CARE REFILLS CROSSACTION EB50 BRUSH SET 12CT. NO INJURY WAS REPORTED.