FDA Adverse Event
Injury
Summary report: N
WILLOW WEARABLE BREAST PUMP
MDR report key: 10857026
·
Received November 17, 2020
Report
- Report Number
- 3012759464-2020-00019
- Event Type
- Injury
- Date Received
- November 17, 2020
- Date of Event
- October 19, 2020
- Report Date
- November 17, 2020
- Manufacturer
- EXPLORAMED NC7, INC.
- Product Code
- HGX
- UDI-DI
- 00858298006446
- PMA / PMN Number
- K191577
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED A TEAR ON THE NIPPLE WHICH WAS TREATED WITH A PRESCRIBED TOPICAL STEROID CREAM. THE CUSTOMER CONTINUED TO PUMP. THE DEVICE WAS NOT RETURNED TO EXPLORAMED NC7 FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE WILLOW BREAST PUMP CAUSED OR CONTRIBUTED TO THE NIPPLE INJURY.
Description of Event or Problem · 1
THE CUSTOMER REPORTED TO (B)(6) CUSTOMER CARE ON (B)(6) 2020 THAT SHE EXPERIENCED A TEAR ON HER NIPPLE. THE CUSTOMER'S OB/ GYN PRESCRIBED A TOPICAL STEROID CREAM. THE CUSTOMER REPORTED PUMPING AS SHE HEALED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1319429 | WILLOW WEARABLE BREAST PUMP | POWERED BREAST PUMP | HGX | EXPLORAMED NC7, INC. | PDW48 | 00858298006446 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |