MAUDE Adverse Event Report: RANIR LLC UP&UP INTRDNTL BR MOD; TOOTHBRUSH, MANUAL

Model Number INTRDNTL BR MOD 16CT

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/25/2019

Event Type  malfunction  

Event Description

The claimant had a wire from the interdental break off and get stuck in his gums.He went to dentist and it cost (b)(6) to get the wire out of gums.Guest is seeking compensation for the dentist visit.He also had a second brush in the package break.

• Brand Name: UP&UP INTRDNTL BR MOD
• Type of Device: TOOTHBRUSH, MANUAL
• 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 stenske ; 6166988880
• MDR Report Key: 9194390
• MDR Text Key: 175842674
• Report Number: 1825660-2019-00635
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: INTRDNTL BR MOD 16CT
• Device Lot Number: 13-010
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/30/2019
• Date Manufacturer Received: 09/30/2019
• 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