FDA Adverse Event
Malfunction
Summary report: N
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
MDR report key: 3970556
·
Received June 2, 2014
Report
- Report Number
- 1419937-2014-00445
- Event Type
- Malfunction
- Date Received
- June 2, 2014
- Date of Event
- May 7, 2014
- Report Date
- May 7, 2014
- Manufacturer
- MEDELA, INC.
- Product Code
- HGX
- PMA / PMN Number
- K031614
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER. IN F/U WITH THE CUSTOMER, THE CUSTOMER STATED THAT THE ORIGINAL PRODUCT WILL BE RETURNED. AS OF THE DATE OF THIS REPORT THE ORIGINAL PRODUCT HAS NOT BEEN RECEIVED. SHOULD ADD'L INFO OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A F/U REPORT WILL BE FILED AT THAT TIME. THE CAUSE OF THE BREACH IN THE REV N TRANSFORMER HAS NOT BEEN DETERMINED AT THIS TIME. IT IS CURRENTLY BEING INVESTIGATED UNDER (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE TRANSFORMER HOUSING FOR THEIR PUMP IN STYLE BREAST PUMP IS CRACKED OPEN, THAT SHE CAN SEE INSIDE THE TRANSFORMER, WHICH IS A SAFETY RISK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322516 | PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE | HGX | MEDELA, INC. | 57063-9207010 | 3113/REV N |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |