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

Model Number BR HDS EF FL VIP 3PK

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/06/2019

Event Type  malfunction  

Event Description

Customer called because the plastic bristles kept falling off on the eq tbp flseff rf 3ct.The purple plastic pieces are coming off as she using them and she claims to have swallowed one of them on 6/11.The bristles were coming out of all 3 of the brush heads.She decided to call after it happened with the third one.She used the last one about 2 weeks.Reviewed trend for the given product and noted no other complaints in the last 12 months for tpe coming out on brush head.

• Brand Name: EQUATE BR HDS EF FL 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 ; 6166988880
• MDR Report Key: 8768200
• MDR Text Key: 150567929
• Report Number: 1825660-2019-00579
• 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: 07/08/2019

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 FL VIP 3PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/11/2019
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/08/2019
• 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