MAUDE Adverse Event Report: RANIR LLC DONTODENT EF PERF ANG; TOOTHBRUSH, POWERED

Model Number	EF PERF ANG BULK TRAY BLU - DM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Translation: dear ladies and gentlemen! last week i bought the active cross universal brush heads from dm's own brand dontodent in (b)(6).Unfortunately, yesterday when the first brush was used, a large number of bristles came loose.

• Brand Name: DONTODENT EF PERF ANG
• Common Device Name: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• MDR Report Key: 12170040
• Report Number: 1825660-2021-00978
• Device Sequence Number: 13822909
• Product Code: JEQ
• UDI-Device Identifier: 00681131129053
• UDI-Public: 681131129053
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: EF PERF ANG BULK TRAY BLU - DM
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/18/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1