ORALBPWRORALCARERFLSSENSIULTRATHINEB60
Received Aug 30, 2023
Report 3000302531-2023-00368 · MDR key 17651914
Device
Generic name
Toothbrush, Powered - Jeq
Manufacturer
Braun Gmbh Werk MarktheidenfeldModel number
EB60Lot number
P3053
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PRODUCT RETURN WAS NOT RECEIVED. PRODUCT RETURN WAS REQUESTED. FULL EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.
Description of Event or Problem
COMES OFF, IT BECOMES DETACHED FROM THE HOLDER, THE BRUSH POPS OFF - ORAL-B [DEVICE BREAKAGE] . CASE NARRATIVE: MALE CONSUMER VIA PHONE STATED THAT THE ORAL-B TOOTHBRUSH HEAD CAME OFF/BECAME DETACHED FROM THE ORAL-B TOOTHBRUSH HOLDER. THE ORAL-B TOOTHBRUSH HEAD POPPED OFF. NO INJURY WAS REPORTED.
Additional Manufacturer Narrative
ON 29-SEP-2023 PRODUCT INVESTIGATION RESULTS: PRODUCT RETURN WAS RECEIVED AND EVALUATED. NO FAILURE COULD BE IDENTIFIED, THE PRODUCT IS ACCORDING TO SPECIFICATIONS.
Description of Event or Problem
COMES OFF, IT BECOMES DETACHED FROM THE HOLDER, THE BRUSH POPS OFF - ORAL-B [DEVICE BREAKAGE]. MALE CONSUMER VIA PHONE STATED THAT THE ORAL-B TOOTHBRUSH HEAD CAME OFF/BECAME DETACHED FROM THE ORAL-B TOOTHBRUSH HOLDER. THE ORAL-B TOOTHBRUSH HEAD POPPED OFF. NO INJURY WAS REPORTED. ON 13-SEP-2023 CASE UPDATE: THE SUSPECT PRODUCT LOT WAS P3053. NO INJURY WAS REPORTED. ON 19-SEP-2023 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 13-SEP-2023: THE SUSPECT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS SENSI ULTRATHIN EB60. THE CONCOMITANT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3709. NO INJURY WAS REPORTED.