FDA Adverse Event
Malfunction
Summary report: N
SIMILAC INFANT NIPPLE AND RING
MDR report key: 14085338
·
Received April 11, 2022
Report
- Report Number
- MW5108920
- Event Type
- Malfunction
- Date Received
- April 11, 2022
- Date of Event
- April 3, 2022
- Report Date
- April 7, 2022
- Manufacturer
- UNK
- Product Code
- FNN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
A BROWN SUBSTANCE WAS NOTED ON THE INSIDE AND BASE OF THE NIPPLE. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 901565 | SIMILAC INFANT NIPPLE AND RING | NIPPLE, LAMBS FEEDING | FNN | UNK | 380323L00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 MO | Female |