MAUDE Adverse Event Report: RANIR LLC EQUATE INTRDNTL BR MOD 20CT; TOOTHBRUSH, MANUAL

Model Number INTRDNTL BR MOD 20CT

Device Problem Device Fell (4014)

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

Event Date 02/21/2019

Event Type  malfunction  

Event Description

Consumer called because some of the bristles on the eq flsbr mod 20ct fell out after one use.

• Brand Name: EQUATE INTRDNTL BR MOD 20CT
• 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: 8405308
• MDR Text Key: 138700113
• Report Number: 1825660-2019-00523
• Device Sequence Number: 0
• Product Code: EFW
• 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: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: INTRDNTL BR MOD 20CT
• Device Lot Number: 64-004
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/22/2019
• Date Manufacturer Received: 02/22/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1