FDA Adverse Event
Malfunction
Summary report: N
BABY BOTTLE SILICONE NIPPLE
MDR report key: 19794606
·
Received July 22, 2024
Report
- Report Number
- MW5157414
- Event Type
- Malfunction
- Date Received
- July 22, 2024
- Date of Event
- June 10, 2024
- Report Date
- June 15, 2024
- Manufacturer
- DR. BROWN'S COMPANY
- Product Code
- FNN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
- Health Professional
- *
Narratives
Description of Event or Problem · 0
BOUGHT TWO DIFFERENT SIZED DR BROWN'S BABY BOTTLE SILICONE NIPPLES (P AND 1). ONE IN EACH SET CONTAINS BLACK DEBRIS WITHIN THE PRODUCT (NOT ON THE SURFACE). REFERENCE REPORT: MW5157415.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 356638 | BABY BOTTLE SILICONE NIPPLE | NIPPLE, LAMBS FEEDING | FNN | DR. BROWN'S COMPANY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 DA | Male |