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 |