MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBRCHGTOOTHBRUSHHANDLE3771GENIUSX20000MODELD706.543.6X; TOOTHBRUSH, POWERED - JEQ

Model Number 3771

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

Complained product will not be not available.

Event Description

Caught my face [skin injury] scratched face [scratch] if you take the head off, the end has broken off / bit that goes into the brush head doesn't securely attach to the head to the toothbrush - oral-b [device breakage] case narrative: female consumer via phone reported that the bit that goes into the oral-b toothbrush head does not securely attach the oral-b toothbrush head to the oral-b toothbrush handle and that the ends of the oral-b toothbrush heads broke off and caught her on the face and scratched it.No serious injury was reported.05-dec-2023 via image: the suspect product was oral-b rechargeable toothbrush handle 3771 genius x 20000 model d706.543.6x.No serious injury was reported.

Manufacturer Narrative

19-mar-2024 product investigation results: complained product received - user handling was identified as root cause for the complaint.

Event Description

Caught my face [skin injury] scratched face [scratch] if you take the head off, the end has broken off / bit that goes into the brush head doesn't securely attach to the head to the toothbrush - oral-b [device breakage] case narrative: female consumer via phone reported that the bit that goes into the oral-b toothbrush head does not securely attach the oral-b toothbrush head to the oral-b toothbrush handle and that the ends of the oral-b toothbrush heads broke off and caught her on the face and scratched it.No serious injury was reported.05-dec-2023 via image: the suspect product was oral-b rechargeable toothbrush handle 3771 genius x 20000 model d706.543.6x.No serious injury was reported.

• Brand Name: ORALBRCHGTOOTHBRUSHHANDLE3771GENIUSX20000MODELD706.543.6X
• 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: 18388792
• MDR Text Key: 331505175
• Report Number: 3000302531-2023-00512
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3771
• Device Lot Number: BH02332143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• 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: Initial
• Patient Sequence Number: 1
• Treatment: ORALBPWRORALCARERFLS (ORAL-B/POWER ORAL CARE REFIL; ORALBPWRORALCARERFLS (ORAL-B/POWER ORAL CARE REFIL
• Patient Sex: Female