MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2015-08-10 for PHILIPS AVENT BREAST PUMP SCF332 manufactured by Philips Electronics Uk Limited.
[23084963]
On 07/12/2015 customer claims her daughter was using the pump and after 15 mins of use noticed she was not getting any milk, when she went to remove the pump the daughter had blisters which had opened with removal. Customer had reported they were going to get medical attention but had not yet at the time of the call.
Patient Sequence No: 1, Text Type: D, B5
[71007878]
On 11/11/2015 product was not returned for evaluation. Based on this event, no further corrective or preventive action is deemed necessary. We will continue monitoring these events in post market surveillance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8021997-2015-00008 |
| MDR Report Key | 4995459 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2015-08-10 |
| Date of Report | 2015-07-29 |
| Date of Event | 2015-07-12 |
| 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 | 4254878169 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS AVENT BREAST PUMP |
| Generic Name | MBREAST PUMP |
| Product Code | HGY |
| Date Received | 2015-08-10 |
| Model Number | SCF332 |
| 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 | GLEMSFORD UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-10 |