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

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Falls out in mouth - oral-b [device breakage] brush head is pulling away from the toothbrush - oral-b [device connection issue].Case narrative: 78 year old male consumer via phone stated that the oral-b toothbrush head was pulling away from the oral-b toothbrush while he was brushing and fell out in his mouth.No injury was reported.

Manufacturer Narrative

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

• 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: 19213034
• MDR Text Key: 341951195
• Report Number: 3000302531-2024-00186
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• 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: ORALBPWRORALCARERFLSSENEB17 (ORAL-B/POWER ORAL CAR
• Patient Age: 78 YR
• Patient Sex: Male