MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-09 for PHILIPS AVENT COMFORT SINGLE ELECTRIC BREAST PUMP SCF332 manufactured by Philips Electronics Uk Limited.
[182524962]
The device has been designed according to safety standards and is safe to use when used according to the dfu. The device has been requested for analysis.
Patient Sequence No: 1, Text Type: N, H10
[182524963]
Customer claims that during the first use, her nipple got stuck in the breast pump funnel, that left her breast sore and bruised. She then developed mastitis. She has been prescribed with antibiotics and pain killers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8021997-2020-00001 |
| MDR Report Key | 9804939 |
| Report Source | CONSUMER |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-09 |
| 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. REBECCA RUSSO |
| Manufacturer Street | 1600 SUMMER STREET |
| Manufacturer City | STAMFORD, CT |
| Manufacturer Country | US |
| 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 SINGLE ELECTRIC BREAST PUMP |
| Generic Name | ELECTRIC BREAST PUMP |
| Product Code | HGX |
| Date Received | 2020-03-09 |
| Model Number | SCF332 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS ELECTRONICS UK LIMITED |
| Manufacturer Address | LOWER ROAD GLEMSFORD, SUFFOLK CO107QS UK CO10 7QS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-09 |