FDA Adverse Event
Malfunction
Summary report: N
WILLOW 3.0 BREAST PUMP
MDR report key: 18060243
·
Received November 1, 2023
Report
- Report Number
- MW5147676
- Event Type
- Malfunction
- Date Received
- November 1, 2023
- Date of Event
- September 21, 2023
- Report Date
- October 23, 2023
- Manufacturer
- WILLOW INNOVATIONS, INC.
- Product Code
- HGX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
PURCHASED THE WILLOW 3.0 BREAST PUMP FROM WILLOW INNOVATIONS, INC. WITHIN 2 WEEKS OF PURCHASE THE PUMPS WERE LOSING FUNCTIONALITY. CUSTOMER SERVICE TRIED TO PROVIDE OTHER TIPS OF USE BEFORE REPLACING ONLY ONE PART, WHICH DID NOT SOLVE THE ISSUES. THE MALFUNCTIONS ARE HURTING MY MILK SUPPLY AND I EXCLUSIVELY PUMP FOR MY NEWBORN. THEY ARE REFUSING TO REFUND MY MONEY. I HAVE ALSO COMPLAINED TO THEM THAT THE PRODUCT IS FALSELY ADVERTISED AS BEING SPILL PROOF AND ABLE TO PUMP IN ANY POSITION. I CANNOT BEND OVER WITHOUT LOSING MILK FROM THE PUMP CONTAINERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1961578 | WILLOW 3.0 BREAST PUMP | PUMP, BREAST, POWERED | HGX | WILLOW INNOVATIONS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Female | Other |