MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-04-28 for AVENT SCF330 manufactured by Philips Electronics Uk Limited.
[73906443]
Use of breast pumps is not known to have caused or contributed to this event. The device has been designed according to safety standards and is safe when used in according to the directions for use. The device has been requested from the consumer for analysis. Device has not been received
Patient Sequence No: 1, Text Type: N, H10
[73906444]
The consumer is claiming that when using the device, she expressed small amount of milk and did not feel well. She went to the hospital where a doctor diagnosed her with infiltrative mastitis. She had to take antibiotics; she had infection in her blood and a temperature of 40degc. She claims to have used the device as specified in the manual, to have stored the device in the special box and to have sterilized the device prior to pumping milk. The consumer also alleges that the device is defective because sometimes it does not make a vacuum air leaks at the junction between the pump body and the bottle that was supplied with the device.
Patient Sequence No: 1, Text Type: D, B5
[112496740]
Use of breast pumps is not known to have caused or contributed to this event. The device has been designed according to safety standards and is safe when used in according to the directions for use. The device has been requested from the consumer for analysis. N 7/20: the device returned from the consumer tested in accordance to specifications. No failure was detected.
Patient Sequence No: 1, Text Type: N, H10
[112496741]
The consumer is claiming that when using the device, she expressed small amount of milk and did not feel well. She went to the hospital where a doctor diagnosed her with infiltrative mastitis. She had to take antibiotics; she had infection in her blood and a temperature of 40degc. She claims to have used the device as specified in the manual, to have stored the device in the special box and to have sterilized the device prior to pumping milk. The consumer also alleges that the device is defective because sometimes it does not make a vacuum air leaks at the junction between the pump body and the bottle that was supplied with the device.
Patient Sequence No: 1, Text Type: D, B5
[112499278]
Use of breast pumps is not known to have caused or contributed to this event. The device has been designed according to safety standards and is safe when used in according to the directions for use. The device has been requested from the consumer for analysis. In 7/20: the device returned from the consumer tested in accordance to specifications. No failure was detected.
Patient Sequence No: 1, Text Type: N, H10
[112499279]
The consumer is claiming that when using the device, she expressed small amount of milk and did not feel well. She went to the hospital where a doctor diagnosed her with infiltrative mastitis. She had to take antibiotics; she had infection in her blood and a temperature of 40degc. She claims to have used the device as specified in the manual, to have stored the device in the special box and to have sterilized the device prior to pumping milk. The consumer also alleges that the device is defective because sometimes it does not make a vacuum air leaks at the junction between the pump body and the bottle that was supplied with the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8021997-2017-00002 |
| MDR Report Key | 6529178 |
| Report Source | CONSUMER |
| Date Received | 2017-04-28 |
| Date of Report | 2017-04-13 |
| Date of Event | 2017-04-04 |
| Date Mfgr Received | 2017-07-19 |
| Date Added to Maude | 2017-04-28 |
| 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 | MISS NINA RUIZ |
| Manufacturer Street | 1600 SUMMER ST. |
| Manufacturer City | STAMFORD 06912 |
| Manufacturer Country | US |
| Manufacturer Postal | 06912 |
| Manufacturer G1 | PHILIPS ELETRONICS UK |
| Manufacturer Street | PHILIPS ELECTRONICS UK LIMITED LOWER ROAD |
| Manufacturer City | GLEMSFORD, SUFFOLK CO10 7QS, |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVENT |
| Generic Name | MANUAL BREAST PUMP |
| Product Code | HGY |
| Date Received | 2017-04-28 |
| Returned To Mfg | 2017-07-14 |
| 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, UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2017-04-28 |