FDA Adverse Event Injury Summary report: N

COLGATE DURAPHAT

MDR report key: 15155922 · Received August 2, 2022

Report

Report Number
MW5111232
Event Type
Injury
Date Received
August 2, 2022
Report Date
July 28, 2022
Manufacturer
COLGATE-PALMOLIVE COMPANY GLOBAL TECHNOLOGY CENTER
Product Code
LBH
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
SW
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

BABY BORN WITH CONGENITAL HYPOTHYROIDISM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2161656 COLGATE DURAPHAT VARNISH, CAVITY LBH COLGATE-PALMOLIVE COMPANY GLOBAL TECHNOLOGY CENTER

Patients

Seq Age Sex Outcome Treatment
1 Female Congenital Anomaly