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 Material Fragmentation (1261); Loose or Intermittent Connection (1371)

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

Event Date 06/16/2020

Event Type  malfunction  

Event Description

Consumer stated the bristles on his eq tbp esyflx rf 3ct were falling off/out of 2 of the heads in the pack of 3."i have used the product before with no problems.I bought it about two months ago.Used it until recently.Individual strands of the brush would come loose in my mouth as i was brushing.".

• 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 ; 6166988880
• MDR Report Key: 10260374
• MDR Text Key: 200048116
• Report Number: 1825660-2020-00783
• Device Sequence Number: 1
• Product Code: JEQ
• UDI-Device Identifier: 00681131129053
• UDI-Public: 681131129053
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/29/2020
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/10/2020
• 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