MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRORALCARERFLSFLOSSACTNEB25BRUSHSET4CT; TOOTHBRUSH, POWERED - JEQ

Model Number EB25

Device Problem No Apparent Adverse Event (3189)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Event Description

Discomfort - mouth [oral discomfort].Brush heads.Falling off - oral-b [device breakage].Case narrative: male consumer via e-mail stated that the oral-b pro deep clean toothbrush heads kept falling off of the oral-b genius 9000 toothbrush.This caused (mouth) discomfort.No serious injury was reported.

Manufacturer Narrative

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

• Brand Name: ORALBPWRORALCARERFLSFLOSSACTNEB25BRUSHSET4CT
• Type of Device: TOOTHBRUSH, POWERED - JEQ
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld D-978 28; GM D-97828
• 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: 18120455
• MDR Text Key: 328032249
• Report Number: 3000302531-2023-00456
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EB25
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2023
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ORALBRCHGTOOTHBRUSHHANDLE3765GENIUS (ORAL-B/RECHAR.
• Patient Sex: Male