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