MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-13 for PHILIPS AVENT MANUAL BREAST PUMP SCF 330/20 manufactured by Philips Electronics Uk Limited.
[55569145]
On (b)(6) 2013, the consumer states she was using the pump and it pulled the nipple. The nipple was stuck in the pump. Consumer stated it took 5 minutes to get her nipple removed from the pump. It is painful for her to feed her child. She states there is some bruising. Consumer states that 2 days later, she still has pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8021997-2013-00003 |
| MDR Report Key | 5971413 |
| Date Received | 2013-03-13 |
| Date of Report | 2013-03-13 |
| Date of Event | 2013-03-04 |
| Date Mfgr Received | 2013-03-08 |
| 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 FERREIRA, SR MGR |
| Manufacturer Street | 1600 SUMMER STREET |
| 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 MANUAL BREAST PUMP |
| Generic Name | MANUAL BREAST PUMP |
| Product Code | HGY |
| Date Received | 2013-03-13 |
| Model Number | SCF 330/20 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS ELECTRONICS UK LIMITED |
| Manufacturer Address | GLEMSFORD UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-13 |