FDA Adverse Event Injury Summary report: N

COL TB CLASSIC/EXTRA CLEAN

MDR report key: 25215099 · Received May 19, 2026

Report

Report Number
3008098744-2026-00002
Event Type
Injury
Date Received
May 19, 2026
Report Date
May 5, 2026
Manufacturer
COLGATE-PALMOLIVE COMPANY (VIETNAM) LTD - MY PHUOC
Product Code
EFW
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
003

Narratives

Description of Event or Problem · 0

THIS IS A SPONTANEOUS REPORT RECEIVED ON (B)(6) 2026 FROM A DOCTOR REGARDING AN ADULT MALE CONSUMER WHO BROKE COL TB CLASSIC/EXTRA CLEAN IN HALF AND ATE THE HANDLE, TRYING TO HURT HIMSELF. NO MEDICAL HISTORY WAS PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING COL TB CLASSIC/EXTRA CLEAN (MANUAL TOOTHBRUSH). THE DOCTOR REPORTED THAT THE CONSUMER BROKE COL TB CLASSIC/EXTRA CLEAN IN HALF AND ATE THE HANDLE, TRYING TO HURT HIMSELF. THERE WAS A SHARP EDGE ON THE HANDLE AND THE DOCTOR INQUIRED IF THE PLASTIC HANDLE OF THE TOOTHBRUSH IS RADIOPAQUE TO SHOW UP ON X-RAY. AN ELECTROCARDIOGRAM (EKG) NOTED A HEART RATE OF 73 BEATS PER MINUTE, NORMAL QRS, NO ST SEGMENT ELEVATION OR DEPRESSION, AND NO EVIDENCE OF THE ISCHEMIC CHANGES. A COMPUTED TOMOGRAPHY (CT) SCAN DID NOT IDENTIFY SAID TOOTHBRUSH HEAD ON THE IMAGES. THE CONSUMER WAS SENT TO SURGERY FOR SUSPECTED INGESTION AND REMOVAL OF TOOTHBRUSH HANDLE. AT THE TIME OF THIS REPORT OUTCOME OF THE EVENTS WAS UNKNOWN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
48990 COL TB CLASSIC/EXTRA CLEAN COL TB CLASSIC/EXTRA CLEAN EFW

Patients

Seq Age Sex Outcome Treatment
1 NA Male Other