FDA Adverse Event
Injury
Summary report: N
MOM COZY
MDR report key: 20854990
·
Received December 4, 2024
Report
- Report Number
- MW5163221
- Event Type
- Injury
- Date Received
- December 4, 2024
- Date of Event
- November 11, 2024
- Report Date
- November 29, 2024
- Manufacturer
- SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD.
- Product Code
- HGX
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
MOMCOZY BREAST PUMP THAT IS WEARABLE IS NOT RECOMMENDED FOR A PUMPING PERSON WITH A BABY IN THE NICU. THE COMPANY HAS TO ADVERTISE THAT. THIS PARENT IS PRODUCING VERY LITTLE BREASTMILK NO MATTER HOW OFTEN THEY PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2290679 | MOM COZY | PUMP, BREAST, POWERED | HGX | SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female | Other |