MAUDE Adverse Event Report: RANIR LLC DM EF II HD ASY; TOOTHBRUSH, POWERED

Model Number	EF II HD ASY BULK BLU
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer stated: borsten fallen aus.Translation: bristles fall out.

• Brand Name: DM EF II HD ASY
• Common Device Name: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• MDR Report Key: 10898672
• Report Number: 1825660-2020-00857
• Device Sequence Number: 2644412
• 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
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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 HD ASY BULK BLU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Distributor Facility Aware Date: 11/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1