MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-01-31 for PHILIPS AVENT MANUAL BREAST PUMP SCF330 manufactured by Philips Electronics Uk Limited.
[98711004]
The device has been designed according to safety standards and is safe to use when used according to the dfu. Device has been requested for analysis.
Patient Sequence No: 1, Text Type: N, H10
[98711005]
Consumer stated that she was using the device per the manual and the device stopped to make a vacuum. She claims that due to this she became ill with lactostasis. She stated that this illness included fever and redness.
Patient Sequence No: 1, Text Type: D, B5
[112498135]
The device has been designed according to safety standards and is safe to use when used according to the dfu. Device has been requested for analysis. Follow-up 1 04/18/2018- device returned for analysis. Based on the analysis of the returned device, the devices is operating according to specification. Mastitis is a secondary complication of an expected side effect and is, therefore, not considered to be caused by the breast pump.
Patient Sequence No: 1, Text Type: N, H10
[112498136]
Consumer stated that she was using the device per the manual and the device stopped to make a vacuum. She claims that due to this she became ill with lactostasis. She stated that this illness included fever and redness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8021997-2018-00001 |
| MDR Report Key | 7232349 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-01-31 |
| Date of Report | 2018-01-15 |
| Date of Event | 2018-01-08 |
| Date Mfgr Received | 2018-01-15 |
| Date Added to Maude | 2018-01-31 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 MANUAL BREAST PUMP |
| Generic Name | MANUAL BREAST PUMP |
| Product Code | HGY |
| Date Received | 2018-01-31 |
| Returned To Mfg | 2018-03-13 |
| Model Number | SCF330 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-01-31 |