MAUDE Adverse Event Report: COLGATE SANXIAO CO., LTD. COL TB MY FIRST

Device Problem Defective Device (2588)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

This is a spontaneous report received on 11 sep 2023 from a consumer regarding her 04-year-old daughter who used col tb my first and the bristles got stuck in her tonsils.There was no relevant medical history provided.On an unspecified date, the reporter's daughter used col tb my first (frequency unknown).It was reported bristles got stuck in the child's tonsils and she was hospitalized for surgery to remove the bristles.Action taken with col tb my first was unknown.At the time of this report, the outcome of the event was resolved.

• Brand Name: COL TB MY FIRST
• Type of Device: COL TB MY FIRST
• Manufacturer (Section D): COLGATE SANXIAO CO., LTD.; no. 8, gaolujie road; guangling district; yangzhou jiangsu, cn 22511 1; CH 225111
• Manufacturer (Section G): COLGATE SANXIAO CO., LTD.; no. 8, gaolujie road; guangling district; yangzhou jiangsu, cn 22511 1; CH 225111
• Manufacturer Contact: humel leonard ; 909 river road; piscataway 08854 ; 7328787930
• MDR Report Key: 17806589
• MDR Text Key: 324116362
• Report Number: 3003205012-2023-00010
• Device Sequence Number: 1
• Product Code: EFW
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 09/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 04 YR
• Patient Sex: Female