MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3765IBRUSH9000; TOOTHBRUSH, POWERED - JEQ

Model Number 3765

Device Problems Material Split, Cut or Torn (4008); Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Event Description

Electric shock [electric shock] charging cable broken/5 mm slit at the base of the handle - oral-b [device breakage] malfunction hazard - oral-b [device physical property issue].Case narrative: consumer via phone stated that their oral-b toothbrush handle charging cable was broken and that there was a malfunction hazard.They experienced electric shock.No serious injury was reported.(b)(6)2022 follow up via phone: the consumer reported that there was a 5 millimeter slit at the base of the oral-b toothbrush handle.No serious injury was reported.

Manufacturer Narrative

The reporter informed the company that the product has been discarded.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3765IBRUSH9000
• 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; mason-montgomery rd; mason 45040
• MDR Report Key: 15257294
• MDR Text Key: 304708520
• Report Number: 3000302531-2022-00320
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3765
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: ORAL-B BRUSHHEADS, VERSION UNKNOWN (ALL OTHER NON-