MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2015-06-22 for PHILIPS AVENT COMFORT MANUAL BREAST PUMP SCF330/20 manufactured by Philips Electronics Uk Ltd..
[55572687]
On (b)(6) 2015 product was requested for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[55572688]
On (b)(6) 2015 consumer claims after using the breast pump for 9 weeks, it has been extremely painful and developed mastitis. She has had several doctors appointments. Consumer feels breast pump does not work well for large breasted women. The cushion that comes with the breast pump is too small and has cut her nipple which over time created a breast infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8021997-2015-00006 |
| MDR Report Key | 5971439 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2015-06-22 |
| Date of Report | 2015-06-22 |
| Date of Event | 2015-06-02 |
| Date Added to Maude | 2016-09-22 |
| 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 | MARY SMITH FERREIRA |
| Manufacturer Street | 1600 SUMMER ST. |
| Manufacturer City | STAMFORD CT 06905 |
| Manufacturer Country | US |
| Manufacturer Postal | 06905 |
| Manufacturer Phone | 2033515949 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PHILIPS AVENT COMFORT MANUAL BREAST PUMP |
| Generic Name | MANUAL BREAST PUMP |
| Product Code | HGY |
| Date Received | 2015-06-22 |
| Model Number | SCF330/20 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS ELECTRONICS UK LTD. |
| Manufacturer Address | GLEMSFORD UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-22 |