MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2015-12-23 for PHILIPS AVENT MANUAL BREAST PUMP SCF330/20 manufactured by Philips Electronics Uk Limited.
[34419013]
This is the first time this type of incident has been reported. Latex is not a material component of the breast pump. It is always possible to have an allergic reaction to a material. However, this is very unlikely with this product, since allergies to both silicone, (the material of the breast pad), and polypropylene, (the material of our pumps), are very rare. Both materials are considered "inert" and have been tested to comply with the iso 10993 standard for biocompatibility, i. E. , both materials are safe and should not cause allergic reactions. This device was also discarded by the consumer and cannot be evaluated.
Patient Sequence No: 1, Text Type: N, H10
[34419014]
Consumer alleges to have received an allergic reaction from using a breast pump. She claims to have developed a rash over her right breast, up onto her neck and facial redness/swelling. She requested refund for her products.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8021997-2015-00013 |
| MDR Report Key | 5327320 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2015-12-23 |
| Date of Report | 2015-11-26 |
| Date of Event | 2015-11-16 |
| Date Mfgr Received | 2015-11-26 |
| Date Added to Maude | 2015-12-24 |
| 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 | NINA RUIZ |
| 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 MANUAL BREAST PUMP |
| Generic Name | MANUAL BREAST PUMP |
| Product Code | HGY |
| Date Received | 2015-12-23 |
| Model Number | SCF330/20 |
| Device Availability | N |
| 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 | 2015-12-23 |