MAUDE Adverse Event Report: COLGATE SANXIAO CO., LTD. COL TB CLASSIC/EXTRA CLEAN

Device Problem Defective Device (2588)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

This is a spontaneous report received on (b)(6) 2022 from a consumer (age and gender unknown), who used col tb classic/extra clean and toothbrush bristle came off and lodged in throat and had a painful experience.There was no relevant medical history provided.On an unknown date, consumer started using col tb classic/extra clean (frequency unspecified).Consumer reported that after brushing teeth with col tb classic/extra clean the bristle came off and lodged in throat.The consumer had to spend most of day in the emergency room and ent clinic.The ent doctor was able to scope and remove the bristle.The consumer described the experience as painful.Action taken with col tb classic/extra clean was unknown.At the time of this report, the event bristles lodged in throat was resolved and outcome of other events was considered unknown.

• Brand Name: COL TB CLASSIC/EXTRA CLEAN
• Type of Device: COL TB CLASSIC/EXTRA CLEAN
• Manufacturer (Section G): COLGATE SANXIAO CO., LTD.; no. 8, gaolujie road; guangling district yangzhou; jiangsu, cn 22511 1; CH 225111
• Manufacturer Contact: leonard humel ; 909 river road; piscataway, NJ 08854 ; 7328787930
• MDR Report Key: 16050389
• MDR Text Key: 306158369
• Report Number: 3003205012-2022-00002
• 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: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Date Manufacturer Received: 12/02/2022
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other