MAUDE Adverse Event Report: RANIR LLC EQUATE MNTB ORB BRIL WH OPT SO 2PK; TOOTHBRUSH, MANUAL

Model Number MNTB ORB BRIL WH OPT SO 2PK

Device Problem Material Disintegration (1177)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2019

Event Type  malfunction  

Event Description

Consumer stated the balls in the middle of the bristles came out while her father was brushing his teeth.

• Brand Name: EQUATE MNTB ORB BRIL WH OPT SO 2PK
• 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 ; 4701 east paris ave. se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 8633119
• MDR Text Key: 146362255
• Report Number: 1825660-2019-00564
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• 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: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MNTB ORB BRIL WH OPT SO 2PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/02/2019
• Date Manufacturer Received: 05/02/2019
• 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