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

Model Number EF II BULK TRAY GRN

Device Problem Degraded (1153)

Patient Problem Insufficient Information (4580)

Event Date 01/28/2021

Event Type  malfunction  

Event 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
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer (Section G): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer Contact: rebekah hamilton ; 6166988880
• MDR Report Key: 11426766
• MDR Text Key: 244191842
• Report Number: 1825660-2021-00915
• Device Sequence Number: 1
• Product Code: JEQ
• UDI-Device Identifier: 00681131129053
• UDI-Public: 681131129053
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EF II BULK TRAY GRN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/28/2021
• Date Manufacturer Received: 01/28/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1