MAUDE Adverse Event Report: RANIR LLC EQUATE BR HDS EF II VIP 3PK; TOOTHBRUSH, POWERED

Model Number BR HDS EF II VIP 3PK

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

Consumer threw product away, product not returned.

Event Description

Consumer stated that the equate flex toothbrush brush head broke once she started to use it.Later it was discovered that the tuft carrier was not attached to the arm.Consumer was not able to use the brush head as the tuft was completely detached.She threw away product.

• Brand Name: EQUATE BR HDS EF II VIP 3PK
• Type of Device: TOOTHBRUSH, POWERED
• 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: 7638631
• MDR Text Key: 112460915
• Report Number: 1825660-2018-00360
• Device Sequence Number: 1
• Product Code: JEQ
• 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: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BR HDS EF II VIP 3PK
• Device Lot Number: 64330
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/07/2018
• Date Manufacturer Received: 06/07/2018
• 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