MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBRCHGTOOTHBRUSHHANDLE3764PRO6000; TOOTHBRUSH, POWERED - JEQ

Model Number 3764

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Manufacturer Narrative

Product return was not received.Product return was requested.Full evaluation will occur upon receipt of product return.

Event Description

Knocked in the face.Blood - skin [skin haemorrhage] brush heads have been no longer staying securely attached to the hand piece, i.E., the brush head comes loose from the hand piece - oral-b [device connection issue].Case narrative: consumer via chat stated that the original oral-b crossaction toothbrush heads no longer stayed securely attached to the oral-b smartseries 6000 toothbrush hand piece, model 3764.The oral-b toothbrush head came loose from the hand piece mid-brushing.They got knocked in the face several times by the ¿vibrating metal" and there was some blood.No serious injury was reported.05-feb-2024 case update: the suspect product lot was n2303.No serious injury was reported.

Manufacturer Narrative

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

Event Description

Knocked in the face.Blood - skin [skin haemorrhage].Brush heads have been no longer staying securely attached to the hand piece, i.E., the brush head comes loose from the hand piece - oral-b [device connection issue].Case narrative: consumer via chat stated that the original oral-b crossaction toothbrush heads no longer stayed securely attached to the oral-b smartseries 6000 toothbrush hand piece, model 3764.The oral-b toothbrush head came loose from the hand piece mid-brushing.They got knocked in the face several times by the ¿vibrating metal" and there was some blood.No serious injury was reported.05-feb-2024 case update: the suspect product lot was n2303.No serious injury was reported.29-feb-2024 product investigation results: the suspect product was confirmed to be oral-b rechargeable toothbrush handle 3764 pro 6000.The concomitant product was confirmed to be oral-b power oral care refills crossaction eb50.No serious injury was reported.

• Brand Name: ORALBRCHGTOOTHBRUSHHANDLE3764PRO6000
• 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: 18657602
• MDR Text Key: 334837305
• Report Number: 3000302531-2024-00028
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3764
• Device Lot Number: R612 20550
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: ORALBPWRORALCARERFLSCROSSACTNEB50 (ORAL-B/POWER OR; ORALBRCHGTOOTHBRUSHHANDLE3764PRO6000 (ORAL-B/RECHA