FDA Adverse Event Injury Summary report: N

BABYATION PUMP

MDR report key: 17604628 · Received August 22, 2023

Report

Report Number
MW5144874
Event Type
Injury
Date Received
August 22, 2023
Date of Event
October 4, 2022
Report Date
August 19, 2023
Manufacturer
BABYATION INC.
Product Code
HGX
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

PUMP DID NOT WORK DESPITE CUSTOMER SUPPORT, MULTIPLE ZOOM MEETINGS LASTING OVER 2 HOURS, REPLACEMENT PARTS AND PUMPS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
301087 BABYATION PUMP PUMP, BREAST, POWERED HGX BABYATION INC.

Patients

Seq Age Sex Outcome Treatment
1 Unknown Disability