MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBRCHGTOOTHBRUSHHANDLE3767SMARTSRSCROSSACTN4000MODELD601.524.3; TOOTHBRUSH, POWERED - JEQ

Model Number D601.524.3

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

Bleeding - cheek - mouth [mouth haemorrhage].Spike went into me cheek.Left a mark - mouth [oral macule].Brush end came off / doesn't seem as secure as it was - oral-b [device breakage].Case narrative: male consumer via e-mail reported that while using his oral-b smart 4000n toothbrush, the end came off and the spike went into his cheek causing bleeding and a mark where the steel entered.He reported that it did not seem as secure as it was from new.No serious injury was reported.

Manufacturer Narrative

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

Manufacturer Narrative

On 06-nov-2023 product investigation results: product return was received and evaluated.No failure could be identified, the product is according to specifications.

Event Description

Bleeding - cheek - mouth [mouth haemorrhage].Spike went into me cheek, left a mark - mouth [oral macule].Brush end came off / doesn't seem as secure as it was - oral-b [device breakage].Case narrative: male consumer via e-mail reported that while using his oral-b smart 4000n toothbrush, the end came off and the spike went into his cheek causing bleeding and a mark where the steel entered.He reported that it did not seem as secure as it was from new.No serious injury was reported.On 09-oct-2023 case update: the suspect product lot number was 3cb31941739.No serious injury was reported.

• Brand Name: ORALBRCHGTOOTHBRUSHHANDLE3767SMARTSRSCROSSACTN4000MODELD601.524.3
• 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): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld D-978 28; GM D-97828
• Manufacturer Contact: mgr. affairs, oral care-see co ; mason business center 8700 ma; son-montgomery rd; mason 45040
• MDR Report Key: 17885086
• MDR Text Key: 325075067
• Report Number: 3000302531-2023-00430
• 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,Followup
• Report Date: 11/14/2023

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: D601.524.3
• Device Lot Number: 3CB31941739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: ORAL-B/POWER ORAL CARE REFILLS/CROSS ACTION (),; ORAL-B/POWER ORAL CARE REFILLS/CROSS ACTION (),
• Patient Sex: Male