MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBRCHGTOOTHBRUSHHANDLE3765GENIUS; TOOTHBRUSH, POWERED - JEQ

Model Number 3765

Device Problem No Apparent Adverse Event (3189)

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

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

Brush heads are no longer staying attached to the hand piece.They come off mid-brushing - oral-b [device breakage] case narrative: consumer via e-mail reported that their oral-b toothbrush heads were no longer staying attached to the oral-b toothbrush hand piece, type 3765 and that they came off mid-brushing.No injury was reported.

• Brand Name: ORALBRCHGTOOTHBRUSHHANDLE3765GENIUS
• 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: 19213074
• MDR Text Key: 341837068
• Report Number: 3000302531-2024-00208
• 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
• 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
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ORALBPWRORALCARERFLS (ORAL-B/POWER ORAL CARE REFIL