MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-12-20 for PHILIPS AVENT MANUAL BREAST PUMP SCF330 manufactured by Philips Electronics Uk Limited.
[62794534]
Use of breast pumps is not known to cause or contribute to this event. This report has been submitted following a retrospective review of past complaints. Device not returned by the consumer.
Patient Sequence No: 1, Text Type: N, H10
[62794535]
The consumer claims to have had infectious matistis in her chest following the use of her manual breast pump. She also claims that the infection spread to the scar of her caesarean section and has caused an abscess in the scar, which has lasted a month.
Patient Sequence No: 1, Text Type: D, B5
[112496591]
Use of breast pumps is not known to cause or contribute to this event. This report has been submitted followings a retrospective review of past complaints. Corrected data: indicated that the manufacturer was located in the us instead of the (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[112496592]
The consumer claims to have had infectious mastitis in her chest following the use of her manual breast pump. She also claims that the infection spread to the scar of her caesarean section and has caused an abscess in the scar, which has lasted a month.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8021997-2016-00005 |
| MDR Report Key | 6188452 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-12-20 |
| Date of Report | 2014-04-03 |
| Date Mfgr Received | 2014-04-03 |
| Date Added to Maude | 2016-12-20 |
| 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 CT 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, 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 MANUAL BREAST PUMP |
| Generic Name | MANUAL BREAST PUMP |
| Product Code | HGY |
| Date Received | 2016-12-20 |
| Model Number | SCF330 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2016-12-20 |