MAUDE Adverse Event Report: RANIR LLC PLACKERS INTRDNTL BR RA 10CT; FLOSS, DENTAL

Model Number INTRDNTL BR RA 10CT

Device Problems Break (1069); Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)

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

Event Date 04/06/2018

Event Type  malfunction  

Event Description

Consumer stated: "i have tried every toothpick on the market and this is the only one that will reach my back teeth.The only thing you have to watch is don¿t over use the same pick or the wire breaks off, i had it happen in my mouth and had to push it out with something else.".

• Brand Name: PLACKERS INTRDNTL BR RA 10CT
• Type of Device: FLOSS, DENTAL
• 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: 7477041
• MDR Text Key: 107198871
• Report Number: 1825660-2017-00307
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 05/01/2018

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: INTRDNTL BR RA 10CT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/06/2018
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 05/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1