MAUDE Adverse Event Report: RANIR LLC DM; TOOTHBRUSH, POWERED

Model Number	EF II BULK TRAY GRN
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Ran20201/461 "kundin hat das produkt gestern in der filiale 2877 gekauft.Sie hat diese gestern abend auch genutzt und es sind gleich sehr viele borsten ausgefallen.Ihr ist aber aufgefallen, dass es überwiegend die blauen borsten sind.Translation: "the customer bought the product yesterday at branch 2877.She also used it yesterday evening and a lot of bristles fell out.But she noticed that it was mostly the blue bristles.".

• Brand Name: DM
• Common Device Name: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• MDR Report Key: 12092718
• Report Number: 1825660-2021-00973
• Device Sequence Number: 936873
• 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): 06/30/2021

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 II BULK TRAY GRN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/07/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1