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

Device Problem Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

Dental caries [dental caries].Pain - lips [lip pain].Cuts - lips [lip injury].Brush heads.Become loose.Space in between - oral-b [device connection issue].Case narrative: male consumer via e-mail stated that he noticed the oral-b toothbrush heads became loose on the oral-b toothbrush and the space in-between nipped onto his lips, cutting them and causing him pain to brush.He also noticed his oral health got worse.No serious injury was reported.10-aug-2023 follow up via e-mail: the consumer reported that since using these devices, more dental caries have formed.The concomitant product lot was ab30451022.No serious injury was reported.

Manufacturer Narrative

Reporter informated the company that the product has been discarded.

• Brand Name: ORALBPWRORALCARERFLS
• 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: 17650386
• MDR Text Key: 322280526
• Report Number: 3000302531-2023-00371
• 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: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: ORALBRCHGTOOTHBRUSHHANDLE3767SMART4500 (ORAL-B/REC).
• Patient Sex: Male