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

Lot Number 0501E1

Device Problem Defective Device (2588)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

Additional information was received from a consumer on 02may2023.The lot number of col tb slim soft charcoal was provided as (b)(6).

• 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, cn 22511 1; CH 225111
• Manufacturer Contact: humel leonard ; 909 river road; piscataway 08854 ; 7328787930
• MDR Report Key: 17008963
• MDR Text Key: 316199908
• Report Number: 3003205012-2022-00009
• 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: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 0501E1
• Date Manufacturer Received: 05/02/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female