ORALBRCHGTOOTHBRUSHHANDLE3764
Received Jul 11, 2024
Report 3000302531-2024-00314 · MDR key 19719772
Device
Generic name
Toothbrush, Powered - Jeq
Manufacturer
Braun Gmbh Werk MarktheidenfeldModel number
3764Lot number
R54950009
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
20-SEP-2024 PRODUCT INVESTIGATION RESULTS: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.
Description of Event or Problem
BRUSH HEADS FALL OFF - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: FEMALE CONSUMER VIA PHONE STATED THAT THE ORAL-B TOOTHBRUSH HEADS FELL OFF OF THE ORAL-B TRIUMPH TOOTHBRUSH, MODEL 3764 MID-BRUSHING. NO INJURY WAS REPORTED. 03-SEP-2024 CASE UPDATE: THE SUSPECT PRODUCT LOT WAS R54950009. THE CONCOMITANT PRODUCT LOT WAS 13153. NO INJURY WAS REPORTED. 12-SEP-2024 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 03-SEP-2024: THE CONCOMITANT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN EB20RX. NO INJURY WAS REPORTED.
Description of Event or Problem
BRUSH HEADS FALL OFF - ORAL-B [DEVICE BREAKAGE] CASE NARRATIVE: FEMALE CONSUMER VIA PHONE STATED THAT THE ORAL-B TOOTHBRUSH HEADS FELL OFF OF THE ORAL-B TRIUMPH TOOTHBRUSH, MODEL 3764 MID-BRUSHING. NO INJURY WAS REPORTED.
Additional Manufacturer Narrative
PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.