MAUDE Adverse Event Report: ORALKLEEN LLC ORALKLEEN; POWERED TOOTHBRUSH

Model Number	V1
Medical Device Problem Codes	Defective Component (2292); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An experienced icu nurse had just started to brush a cooperative patient's teeth using one of the prepackaged replacement toothbrush heads.She said the patient barely bit down and the brush head popped off.It landed on his tongue and she quickly stuck her fingers inside his mouth to fish it out and save it.The failed parts were gathered and returned to a company representative for investigation.

• Brand Name: ORALKLEEN
• Common Device Name: POWERED TOOTHBRUSH
• Manufacturer (Section D): ORALKLEEN LLC; 1 n. 1st st.; ste 7200; phoenix AZ 85004
• Manufacturer (Section G): SHENZHEN RISUN TECHNOLOGY CO., LTD; building a, no.6 of xinmu road; xinmu community; pinghu, shenzhen guangdong 51811 1; CH 518111
• Manufacturer Contact: president, coo kenzler ; 1 n. 1st st; ste 7200; phoenix, AZ 85004 ; 6027672422
• MDR Report Key: 16462812
• Report Number: 3018418236-2023-00001
• Device Sequence Number: 2493539
• Product Code: JEQ
• UDI-Device Identifier: 00850030081001
• UDI-Public: 00850030081001
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Inspection,Other,Replace
• Type of Report: Initial
• Report Date (Section B): 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: V1
• Device Catalogue Number: 6150100
• Device Lot Number: 0422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown