MAUDE Adverse Event Report: RANIR LLC UP & UP BR HDS SMSNC PRO ADV NP 3PK; TOOTHBRUSH, POWERED

Model Number BR HDS SMSNC PRO ADV NP 3PK

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/26/2021

Event Type  malfunction  

Event Description

The consumer stated: the heads are much smaller than the ones that came with the toothbrushes.Also, one of the bristles came out in my daughter's mouth.I think it would have been worth paying the extra cost to get the name brand heads in this case.Also, it fits on the kids sonicare brush, but it seems like just barely.

• Brand Name: UP & UP BR HDS SMSNC PRO ADV NP 3PK
• 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: julia bowen ; 6166988880
• MDR Report Key: 13517501
• MDR Text Key: 288180252
• Report Number: 1825660-2022-01049
• Device Sequence Number: 1
• Product Code: JEQ
• UDI-Device Identifier: 1373381567
• UDI-Public: 1373381567
• Combination Product (y/n): N
• 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: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BR HDS SMSNC PRO ADV NP 3PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/13/2022
• Date Manufacturer Received: 01/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1