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

Model Number BR HDS SMSNC II 3PK

Device Problem Positioning Problem (3009)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/13/2021

Event Type  malfunction  

Event Description

112386779 guest says this item injured her teeth she ended up getting a chip from this item not staying in place as advertised.Contact info not provided, product not returned.

• Brand Name: UP&UP BR HDS SMSNC II 3PK
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• MDR Report Key: 12258928
• MDR Text Key: 266494843
• Report Number: 1825660-2021-00986
• Device Sequence Number: 1
• Product Code: JEQ
• UDI-Device Identifier: 00071031584524
• UDI-Public: 071031584524
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BR HDS SMSNC II 3PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/13/2021
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1