MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-09-21 for PHILIPS AVENT COMFORT MANUAL BREAST PUMP SCF330 manufactured by Philips Electronics Uk Limited.
[121033463]
Lactostatsis occurs when milk stays still in the breast, not from being removed from the breast. The device has been designed according to safety standards and is safe to use when used according to the dfu. Additional information will be provided if it becomes available.
Patient Sequence No: 1, Text Type: N, H10
[121033464]
The consumer claimed that she has not been satisfied with the device and has developed lactostasis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8021997-2018-00004 |
| MDR Report Key | 7898455 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-09-21 |
| Date of Report | 2018-08-31 |
| Date of Event | 2018-08-01 |
| Date Mfgr Received | 2018-08-31 |
| Date Added to Maude | 2018-09-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NINA RUIZ |
| Manufacturer Street | 1600 SUMMER STREET |
| Manufacturer City | STAMFORD CT 06912 |
| Manufacturer Country | US |
| Manufacturer Postal | 06912 |
| Manufacturer G1 | PHILIPS ELECTRONICS UK LIMITED |
| Manufacturer Street | LOWER ROAD |
| Manufacturer City | GLEMSFORD, SUFFOLK CO107QS |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CO10 7QS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS AVENT COMFORT MANUAL BREAST PUMP |
| Generic Name | MANUAL BREAST PUMP |
| Product Code | HGY |
| Date Received | 2018-09-21 |
| Model Number | SCF330 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS ELECTRONICS UK LIMITED |
| Manufacturer Address | LOWER ROAD GLEMSFORD, CO107QS UK CO10 7QS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-21 |