FDA Adverse Event
Other
Summary report: N
PUMP IN STYLE ADVANCED BREASTPUMP SHOULDER BAG
MDR report key: 1880472
·
Received October 13, 2010
Report
- Report Number
- 1419937-2010-00025
- Event Type
- Other
- Date Received
- October 13, 2010
- Date of Event
- July 8, 2009
- Report Date
- July 8, 2009
- Manufacturer
- MEDELA, INC.
- Product Code
- HGX
- PMA / PMN Number
- K031614
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER RETURNED THE PUMP FOR EVALUATION/ INVESTIGATION. NO EVALUATION WAS PERFORMED; DEVICE WAS SCRAPPED. NO CONCLUSION CAN BE DRAWN. AS PART OF COMPLAINT REMEDIATION ACTIVITIES, HISTORICAL COMPLAINT RECORDS ARE BEING REVIEWED FOR POSSIBLE ADVERSE EVENTS. MEDELA IS COMMITTED TO CREATING AN EFFECTIVE COMPLAINT HANDLING PROCESS TO ASSURE COMPLAINTS ARE PROCESSED IN A TIMELY MANNER AND EVALUATED FOR PART 803 REPORTING.
Description of Event or Problem · 1
CUSTOMER CALLED STATING THAT THE PUMP HURTS; SHE HAD USED THE ONE IN THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP IN STYLE ADVANCED BREASTPUMP SHOULDER BAG | PUMP, BREAST, POWERED | HGX | MEDELA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |