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

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

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

Cut - face [skin laceration]; metal that holds the toothbrush head in part of it broke off and the toothbrush head came off - oral-b [device breakage].Case narrative: consumer via chat reported that the part of the metal that held the oral-b toothbrush head in broke off and the oral-b toothbrush head came off.The metal part cut their face while they were brushing.No serious injury was reported.

• Brand Name: ORALBRCHGTOOTHBRUSHHANDLE
• 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: 17729709
• MDR Text Key: 323188414
• Report Number: 3000302531-2023-00378
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: ORAL-B/POWER ORAL CARE REFILLS (),