MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-08-10 for PHILIPS AVENT MANUAL BREAST PUMP SCF332/01 manufactured by Philips Electronics Uk Limited.
[23084987]
On (b)(4) 2015 attempted to contact consumer. Requested a call back. Once contact is made, product return for eval will be requested.
Patient Sequence No: 1, Text Type: N, H10
[23084988]
On (b)(6) 2015 consumer states after using the breast pump she developed mastitis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8021997-2015-00009 |
| MDR Report Key | 4995446 |
| Report Source | CONSUMER |
| Date Received | 2015-08-10 |
| Date of Report | 2015-08-07 |
| Date of Event | 2015-08-04 |
| Date Added to Maude | 2015-08-12 |
| 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 | 3 |
| Brand Name | PHILIPS AVENT MANUAL BREAST PUMP |
| Generic Name | MANUAL BREAST PUMP |
| Product Code | HGY |
| Date Received | 2015-08-10 |
| Model Number | SCF332/01 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2015-08-10 |