MAUDE Adverse Event Report: RANIR LLC BR HDS SMSNC PREM ANTIPLQ 2PK; TOOTHBRUSH, POWERED

Model Number	BR HDS SMSNC PREM ANTIPLQ 2PK
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer stated when i was using ranir premium antiplaque sonicare toothbrush head replacement.The tufts came out.I swallowed a few and spit out the blue.

• Brand Name: BR HDS SMSNC PREM ANTIPLQ 2PK
• Common Device Name: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• MDR Report Key: 10877280
• Report Number: 1825660-2020-00845
• Device Sequence Number: 2744554
• Product Code: JEQ
• UDI-Device Identifier: 00713733815673
• UDI-Public: 713733815673
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 11/20/2020

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: No Information
• Device Model Number: BR HDS SMSNC PREM ANTIPLQ 2PK
• Device Lot Number: 278347
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1