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

Model Number	EF II BULK TRAY GRN
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Ran2021/62 aufsteckbürsten active clean young unsere beiden söhne benutzen beide die zahnbürste dontodent aktive young.Wir kaufen dazu immer die passenden aufsätze im 3er pack.Allerdings verlieren die aufsätze in letzter zeit die bürstenhaare.Translation: our two sons both use the toothbrush dontodent active young.We always buy the matching attachments in a pack of 3.However, the attachments have been losing brush hair recently.

• Brand Name: DONTODENT EF II
• Common Device Name: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• MDR Report Key: 11426766
• Report Number: 1825660-2021-00915
• Device Sequence Number: 3725480
• 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): 03/05/2021

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: 01/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1