MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3758IO9SRSM9; TOOTHBRUSH, POWERED - JEQ

Model Number 3758

Device Problems Vibration (1674); Connection Problem (2900)

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

Event Type  malfunction  

Manufacturer Narrative

Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.

Event Description

Brush head ¿jumps¿ off the magnet mid-brushing and the toothbrush/brush head then vibrates very strongly - oral-b [device connection issue].Case narrative: male consumer via e-mail stated that the oral-b toothbrush head ¿jumped¿ off of the magnet mid-brushing with their oral-b io series 9n toothbrush and the oral-b toothbrush/toothbrush head then vibrated very strongly, making brushing unpleasant.No injury was reported.

Event Description

Brush head ¿jumps¿ off the magnet mid-brushing and the toothbrush/brush head then vibrates very strongly - oral-b [device connection issue] case narrative: male consumer via e-mail stated that the oral-b toothbrush head ¿jumped¿ off of the magnet mid-brushing with their oral-b io series 9n toothbrush and the oral-b toothbrush/toothbrush head then vibrated very strongly, making brushing unpleasant.No injury was reported.(b)(6)2022 case update: the suspect product lot was ah04010059.No injury was reported.

Manufacturer Narrative

(b)(6)2022 product investigation results: product return was received and investigated.Product investigation results showed that the complaint is caused by external force like dropping lwhich led to a deformation of the adapter upper rim.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3758IO9SRSM9
• 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: 14166483
• MDR Text Key: 299044695
• Report Number: 3000302531-2022-00159
• 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,Followup
• Report Date: 09/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3758
• Device Lot Number: AH04010059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: ORALBPWRPWRORALCARERFLSIOSRS (ORAL-B POWER/POWER O; ORALBPWRPWRORALCARERFLSIOSRS (ORAL-B POWER/POWER O
• Patient Sex: Male