MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3765; TOOTHBRUSH, POWERED - JEQ

Model Number 3765

Device Problems Material Discolored (1170); Loose or Intermittent Connection (1371); Structural Problem (2506)

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 coming loose - oral-b [device connection issue].Metal pin on the handle is noticeably thinner than the one on the toothbrushes - oral-b [device physical property issue].Tip has a slight black discoloration - oral-b [device colour issue].Case narrative: male consumer via e-mail stated that the oral-b toothbrush head was coming loose from their oral-b toothbrush (model 3765) at regular intervals, and then several times during a single brushing session.The metal pin on the handle was noticeably thinner than the one on the oral-b toothbrushes belonging to his wife and children.Furthermore, the tip had a slight black discoloration.No injury was reported.

Manufacturer Narrative

14-dec-2022 product investigation results: product return was received and investigated.Product investigation results showed that the complaint is caused by a breakage of the tip of the driving shaft due to improper consumer handling, storing and cleaning of the product.

Event Description

Brush head coming loose - oral-b [device connection issue].Metal pin on the handle is noticeably thinner than the one on the toothbrushes - oral-b [device physical property issue].Tip has a slight black discoloration - oral-b [device colour issue].Case narrative: male consumer via e-mail stated that the oral-b toothbrush head was coming loose from their oral-b toothbrush (model 3765) at regular intervals, and then several times during a single brushing session.The metal pin on the handle was noticeably thinner than the one on the oral-b toothbrushes belonging to his wife and children.Furthermore, the tip had a slight black discoloration.No injury was reported.02-nov-2022 case update: the suspect product lot was bc910282021.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3765
• 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; mason-montgomery rd; mason 45040
• MDR Report Key: 15485386
• MDR Text Key: 300577881
• Report Number: 3000302531-2022-00353
• 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: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3765
• Device Lot Number: BC910282021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• 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: ORAL-B BRUSHHEADS, VERSION UNKNOWN (NOT APPLICABLE; ORAL-B BRUSHHEADS, VERSION UNKNOWN (NOT APPLICABLE
• Patient Sex: Male