MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3764; TOOTHBRUSH, POWERED - JEQ

Model Number 3764

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Event Description

Cut myself on the shaft [skin laceration].Brush head falls off the shaft - oral-b [device breakage].The shaft is clearly very worn.It is blade sharp - oral-b [device physical property issue].Case narrative: consumer via e-mail stated that their oral-b toothbrush heads fall off of their oral-b toothbrush handle shaft because it is clearly very worn.No injury was reported.(b)(6) 2023 via e-mail: consumer stated that they cut themselves on the shaft of their oral-b toothbrush handle and it is blade sharp.No serious injury was reported.

Manufacturer Narrative

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

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3764
• 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: 18194202
• MDR Text Key: 330070004
• Report Number: 3000302531-2023-00470
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: DA
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3764
• 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: ORALBPWRORALCARERFLS (ORAL-B/POWER ORAL CARE REFIL