MAUDE Adverse Event Report: RANIR LLC PLACKERS KIDS' DUAL GRIPZ; FLOSS, DENTAL

Model Number PLACKERS KIDS' DUAL GRIPZ

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/18/2021

Event Type  malfunction  

Event Description

Her son has swallowed one of the kids double grips.Would like to do an xray on him but they're not sure if there¿s metal in them, not sure if it would show up on the film.

Event Description

Her son has swallowed one of the kids double grips.Would like to do an xray on him but they're not sure if there¿s metal in them, not sure if it would show up on the film.

• Brand Name: PLACKERS KIDS' DUAL GRIPZ
• 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: julia bowen ; 6166988880
• MDR Report Key: 13018580
• MDR Text Key: 285670012
• Report Number: 1825660-2021-01035
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 5108011451
• UDI-Public: 5108011451
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/16/2021

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: PLACKERS KIDS' DUAL GRIPZ
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/18/2021
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1