MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3766; TOOTHBRUSH, POWERED - JEQ

Model Number 3766

Device Problems Degraded (1153); Loose or Intermittent Connection (1371)

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

Toothbrush itself is very smooth and also does not stay in place and lying down properly.- oral-b [device connection issue].Rust forms - oral-b [device physical property issue].Case narrative: male consumer via e-mail stated that the oral-b toothbrush (pin) itself was very smooth and the oral-b toothbrush head refill did not stay in place or lie down properly.He also reported that rust would form.No injury was reported.

Manufacturer Narrative

03-mar-2023 product investigation results: complained product received user handling was identified as root cause for the complaint.

Event Description

Toothbrush itself is very smooth and also does not stay in place and lying down properly - oral-b [device connection issue] rust forms - oral-b [device physical property issue] case narrative: male consumer via e-mail stated that the oral-b toothbrush (pin) itself was very smooth and the oral-b toothbrush head refill did not stay in place or lie down properly.He also reported that rust would form.No injury was reported.20-jan-2023 case update: the suspect product was oral-b power rechargeable toothbrush handle 3766.The suspect product lot was 2cb90621911.No injury was reported.03-mar-2023 case update: the concomitant product lot (oral-b power power oral care refills crossaction eb50black) was n1083.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3766
• 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: 15930882
• MDR Text Key: 307834559
• Report Number: 3000302531-2022-00438
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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: 03/15/2023

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: 3766
• Device Lot Number: 2CB90621911
• 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: 12/07/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2023
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: ORALBPWRPWRORALCARERFLSCROSSACTNEB50BLACK (ORAL-B; ORALBPWRPWRORALCARERFLSCROSSACTNEB50BLACK (ORAL-B; ORALBPWRPWRORALCARERFLSSENSIULTRATHINEB60 (ORAL-B; ORALBPWRPWRORALCARERFLSSENSIULTRATHINEB60 (ORAL-B; TOOTHPASTE (),; TOOTHPASTE (),
• Patient Sex: Male