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 |