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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Eye Injury (1845); Hypersensitivity/Allergic reaction (1907); Swelling (2091); Thrombosis (2100); Thrombus (2101); Injury (2348); Reaction (2414)

Event Date 07/06/2019

Event Type  Injury  

Event Description

Allergic reaction [hypersensitivity].Blisters in my mouth [oral mucosal blistering].Lips were all swollen [lip swelling].Lips were filled with pus [oral pustule].Blood clots in her mouth [thrombosis].Couldn't go to work today because of it [loss of personal independence in daily activities].Had problems with eyes [eye disorder].Had problems with throat [pharyngeal disorder].This is a spontaneous report received from an adult female consumer (age unknown) on (b)(6) 2019 who had an allergic reaction, developed blisters in mouth, lips were all swollen and filled with pus, had blood clots in mouth, had problems continued in additional info section with everything from the neck up like mouth, lips, throat, and eyes and could not go to work due to events after using col tb classic/extra clean.There was no relevant medical history provided.On (b)(6) 2019, consumer used col tb classic/extra clean for the first time.Consumer reported she had an allergic reaction and her mouth "broke out" on (b)(6).She reported having blisters and blood clots in her mouth, she "had problems with everything from the neck up.Mouth, lips, throat, eyes".Consumer reported that she woke up with swollen pus filled lips on (b)(6).Consumer went to the hospital (date not provided) and reported having a cat scan (results unknown).She also reported being unable to go to work on (b)(6) due to the events.Action taken with col tb classic/extra clean was unknown.At the time of report, outcome of the events were unknown.

• Brand Name: COL TB CLASSIC/EXTRA CLEAN
• Type of Device: COL TB CLASSIC/EXTRA CLEAN
• Manufacturer (Section G): COLGATE SANXIAO CO., LTD.; no.1; sanxiao road; yangzhou, jiangsu, jiangsu 22511 1; CH 225111
• Manufacturer Contact: leonard humel ; 909; river road; piscataway, NJ 08854 ; 7328787930
• MDR Report Key: 8788131
• MDR Text Key: 150968588
• Report Number: 3003205012-2019-00001
• 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: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2019
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other