MAUDE Adverse Event Report: RANIR LLC UP&UP MNTB ORB FL SO 4PK; TOOTHBRUSH, MANUAL

Model Number MNTB ORB FL SO 4PK

Device Problem Component Falling (1105)

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

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

Product was not returned, no consumer contact information provided.

Event Description

Consumer purchased a four pack and the little plastic pieces in the toothbrushes fall out--says almost choked on them.

• Brand Name: UP&UP MNTB ORB FL SO 4PK
• 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
• MDR Report Key: 7578835
• MDR Text Key: 110515725
• Report Number: 1825660-2018-00343
• 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: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MNTB ORB FL SO 4PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/17/2018
• Date Manufacturer Received: 05/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1