MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRORALCARERFLSCROSSACTNEB50; TOOTHBRUSH, POWERED - JEQ

Model Number EB50

Device Problem Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Nearly causing me to choke [choking sensation] metal prong slid up and cut face just under nose - skin [skin laceration] brushes.Come off in mouth - oral-b [device breakage] brushes have not been a tight fit on handle - oral-b [device connection issue] case narrative: male consumer via e-mail stated that the oral-b toothbrush heads were not fitting tight on the oral-b toothbrush handle and came off in his month, nearly causing him to choke.Recently, when the oral-b toothbrush head came off in his month, the metal prong slid up and cut his face just under his nose.No serious injury was reported.

• Brand Name: ORALBPWRORALCARERFLSCROSSACTNEB50
• 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: 18428864
• MDR Text Key: 331790836
• Report Number: 3000302531-2023-00519
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EB50
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ORALBRCHGTOOTHBRUSHHANDLE (ORAL-B/RECHARGEABLE TOO
• Patient Sex: Male