MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. GUM CRAYOLA FLOSSER

Model Number 897RZ

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Choking (2464)

Event Date 05/14/2019

Event Type  Injury  

Event Description

We recently started using the gum crayola kids flossers and tonight, my (b)(6) somehow got one of the flossers completely inside her mouth and into her throat, and she was choking on it.Luckily she coughed it out and it came out of her throat/mouth when she puked from chocking on it and she is okay.

• Brand Name: GUM CRAYOLA FLOSSER
• Type of Device: FLOSSER
• Manufacturer (Section D): SUNSTAR AMERICAS, INC.; 301 east central road; schaumburg IL 60195
• Manufacturer (Section G): SUNSTAR AMERICAS, INC.; 301 east central road; schaumburg IL 60195
• Manufacturer Contact: deanna anderson ; 301 east central road; schaumburg, IL 60195 ; 8477944241
• MDR Report Key: 13047902
• MDR Text Key: 284477816
• Report Number: 0001413787-2021-00018
• Device Sequence Number: 1
• Product Code: JES
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 897RZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 12/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR
• Patient Sex: Female
• Patient Weight: 15 KG