MAUDE Adverse Event Report: COLGATE SANXIAO CO., LTD. COL TB SLIM SOFT CHARCOAL

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problems Asthma (1726); Anxiety (2328); Discomfort (2330); Choking (2464); Foreign Body In Patient (2687); Cough (4457)

Event Type  Injury  

Event Description

This is a spontaneous report received on 08jan2022 from an adult male consumer regarding his female partner (age unknown) who stated that col tb slim soft charcoal bristles from the brush were defectively detached and made their way to the back of her tongue, sensed a sensation in the back of her throat, causing her to panic and choke instantly, increased the intensity of the asthma attack, had irritable lungs and coughing, was uncomfortable and as well as the traumatic experience.The consumer's medical history included asthma.On an unspecified date, consumer started using col tb slim soft charcoal (frequency unknown).On an unknown date, the consumer experienced an unspecified sensation in the back of her throat as she was brushing her teeth.The reporter stated the "bristles from the brush it's self must be faulty or defective and in fact come detached from the brush".The reporter stated bristles "made their way to the back of her tongue and caused her to panic" and "caused her choke instantly breathing back the bristles into her lungs".The consumer experienced an asthma attack which required the consumer to go to the hospital for unspecified treatment.The reporter indicated his partner would also need to see her doctor to have her lungs screened for foreign material.At the time of reporting, the consumer was experiencing "irritable lungs", coughing and "uncomfortability".The reporter stated his partner had a "traumatic experience".Action taken with col tb slim soft charcoal bristles was unknown.At the time of this report, outcome of the events was unknown.

• Brand Name: COL TB SLIM SOFT CHARCOAL
• Type of Device: COL TB SLIM SOFT CHARCOAL
• Manufacturer (Section G): COLGATE SANXIAO CO., LTD.; no. 8, gaolujie road; guangling district; yangzhou jiangsu, 22511 1; CH 225111
• Manufacturer Contact: leonard humel ; 909 river road; piscataway 08854 ; 7328787930
• MDR Report Key: 13340841
• MDR Text Key: 289174018
• Report Number: 3003205012-2022-00001
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 01/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Date Manufacturer Received: 01/08/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female