MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRORALCARERFLSDUALACTNEB417BRUSHSET3CT; TOOTHBRUSH, POWERED - JEQ

Model Number EB417

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

Event Description

Pinching the inside of lip [lip injury] lower bristle mount detachment - oral-b [device breakage] case narrative: male consumer via phone stated that the oral-b toothbrush head kept pinching the inside of his lip.The oral-b toothbrush head had a lower bristle mount detachment.No serious injury was reported.

Manufacturer Narrative

Complained product will not be not available.

• Brand Name: ORALBPWRORALCARERFLSDUALACTNEB417BRUSHSET3CT
• 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: 19071881
• MDR Text Key: 339722566
• Report Number: 3000302531-2024-00174
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EB417
• 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: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (A
• Patient Sex: Male