MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS; TOOTHBRUSH, POWERED - JEQ

Model Number UNSP REG#-20220421085622

Device Problems Break (1069); Loose or Intermittent Connection (1371); Connection Problem (2900); Naturally Worn (2988)

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 comes off - oral-b [device breakage].Brush head is very loosely attached to the metal pin - oral-b [device connection issue].Brush head holder has become worn down - oral-b [device physical property issue].Case narrative: male consumer via phone stated that the oral-b toothbrush head came off in his mouth while brushing with his oral-b genius toothbrush, model number 3765.The oral-b toothbrush head holder has become worn down and the oral-b toothbrush head was very loosely attached to the metal pin.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS
• 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: 14166463
• MDR Text Key: 299045322
• Report Number: 3000302531-2022-00155
• 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: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNSP REG#-20220421085622
• Device Lot Number: IC6856A
• 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: ORALBPWRPWRORALCARERFLSSENCLEAN (ORAL-B POWER/POWE
• Patient Sex: Male