PHILIPS AVENT COMFORT DOUBLE ELECTRIC BREAST PUMP
Report
- Report Number
- 8021997-2016-00009
- Event Type
- Injury
- Date Received
- December 20, 2016
- Report Date
- November 24, 2016
- Manufacturer
- PHILIPS ELECTRONICS UK LIMITED
- Product Code
- HGX
- PMA / PMN Number
- K161532
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
DEVICE HAS BEEN REQUESTED FROM CONSUMER FOR ANALYSIS. USE OF BREAST PUMPS IS NOT KNOWN TO CAUSE OR CONTRIBUTE TO THIS EVENT. REQUESTED, BUT NOT RETURNED.
USE OF BREAST PUMPS IS NOT KNOWN TO HAVE CAUSE OF CONTRIBUTED TO THIS EVENT. THE DEVICE HAS BEEN DESIGNED ACCORDING TO SAFETY STANDARDS AND IS SAFE WHEN USED IN ACCORDING TO THE DFU. THE DEVICE HAS BEEN REQUESTED FROM THE CONSUMER FOR ANALYSIS. SUPPLEMENTAL REPORT: THE CONSUMER RETURNED THE DEVICE AND IT TESTED IN ACCORDANCE TO THE SPECIFICATIONS. NO FAILURE WAS FOUND.
USE OF BREAST PUMPS IS NOT KNOWN TO HAVE CAUSE OF CONTRIBUTED TO THIS EVENT. THE DEVICE HAS BEEN DESIGNED ACCORDING TO SAFETY STANDARDS AND IS SAFE WHEN USED IN ACCORDING TO THE DFU. THE DEVICE HAS BEEN REQUESTED FROM THE CONSUMER FOR ANALYSIS. SUPPLEMENTAL REPORT: THE CONSUMER RETURNED THE DEVICE AND IT TESTED IN ACCORDANCE TO THE SPECIFICATIONS. NO FAILURE WAS FOUND.
THE CONSUMER SPOKE ABOUT 'MASTITIS' WHEN EXPLAINING AN ISSUE WITH THE BREAST PUMP CUSHION.
THE CONSUMER SPOKE ABOUT 'MASTITIS' WHEN EXPLAINING AN ISSUE WITH THE BREAST PUMP CUSHION.
THE CONSUMER SPOKE ABOUT 'MASTITIS' WHEN EXPLAINING AN ISSUE WITH THE BREAST PUMP CUSHION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 842065 | PHILIPS AVENT COMFORT DOUBLE ELECTRIC BREAST PUMP | ELECTRIC BREAST PUMP | HGX | PHILIPS ELECTRONICS UK LIMITED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |