MAUDE Adverse Event Report: UNSPECIFIED MANUFACTURER ORALBPWRORALCARERFLSPRECISIONCLEANEB25BRUSHSET8CT; TOOTHBRUSH, POWERED - JEQ

Model Number EB25

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Unspecified Tissue Injury (4559)

Event Type  malfunction  

Manufacturer Narrative

Product return was requested or its in transport.Evaluation will occur upon receipt of product return.

Event Description

Pain mouth [oral pain] pinch the tongue (touch) [tongue injury] pinch the cheek (check) [mouth injury] brush head seem to become loose at the point of attachment to the toothbrush - oral-b [device connection issue] wear indicator on the brushes never changes as it should to indicate time to replace - oral-b [device physical property issue] do you feel these are not genuine oral-b brush heads? [suspected counterfeit product] case narrative: a consumer via chatbot stated that the oral-b toothbrush head became loose at the point of attachment to the oral-b toothbrush and pinched their tongue and cheek.The wear indicator on the oral-b toothbrush also never changed as it should have to indicate it was time to replace.No serious injury was reported.11-apr-2024 follow up via digital safety assessment survey: a 73 year old female reported that she also experienced mouth pain.No serious injury was reported.

• Brand Name: ORALBPWRORALCARERFLSPRECISIONCLEANEB25BRUSHSET8CT
• Type of Device: TOOTHBRUSH, POWERED - JEQ
• Manufacturer (Section G): UNSPECIFIED MANUFACTURER; unspecified address; unspecified city
• Manufacturer Contact: mgr. affairs, oral care-see co ; mason business center 8700 ma; son-montgomery rd; mason 45040
• MDR Report Key: 19213032
• MDR Text Key: 342044086
• Report Number: 3000302531-2024-00204
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EB25
• Device Lot Number: 99345924
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ORALBRCHGTOOTHBRUSHHANDLE (ORAL-B/RECHARGEABLE TOO
• Patient Age: 73 YR
• Patient Sex: Female