FDA Adverse Event
Malfunction
Summary report: N
COLGATE ULTRA SOFT GUM HEALTH TOOTHBRUSH 2 PACK
MDR report key: 20246899
·
Received September 17, 2024
Report
- Report Number
- MW5159685
- Event Type
- Malfunction
- Date Received
- September 17, 2024
- Date of Event
- September 12, 2024
- Report Date
- September 13, 2024
- Manufacturer
- COLGATE-PALMOLIVE COMPANY
- Product Code
- EFW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
COLGATE IS SELLING AN 'ULTRA SOFT GUM HEALTH' TOOTHBRUSH WITH BRISTLES THAT FALL OUT IMMEDIATELY. ONE WEDGED IN MY GUMLINE LIKE A FISH BONE ON FIRST USE. THE REVIEWS ON TARGET AND WALMART SAY THE SAME THING. I'M CONCERNED THAT THE CLEAR BRISTLES AND NON-DEGRADING NATURE OF THE NYLON WOULD MAKE THESE A PERFORATION NIGHTMARE IF THEY WERE SWALLOWED OR INHALED. THESE NEED TO BE RECALLED. PURCHASED BY WALMART GROCERY ONLINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2295344 | COLGATE ULTRA SOFT GUM HEALTH TOOTHBRUSH 2 PACK | TOOTHBRUSH, MANUAL | EFW | COLGATE-PALMOLIVE COMPANY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other |