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 2014-03-10 for PHILIPS AVENT NIPLETTE SCF 152/02 manufactured by Philips Electronics Uk Ltd..
[55578119]
On (b)(6) 2014 consumer stated she has an inverted nipple and decided to try the niplette. Consumer was using the full force of the niplette. The consumer was educated on the dfu that excessive suction force on the nipple can cause bleeding to occur. Consumer stated she wanted to try the product again before returning. Will follow up again with the consumer in a week.
Patient Sequence No: 1, Text Type: N, H10
[55578120]
On (b)(6) 2014 received a call from the consumer. Consumer states that the philips avent niplette caused bleeding on the left nipple.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8021997-2014-00003 |
| MDR Report Key | 5971422 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2014-03-10 |
| Date of Report | 2014-03-10 |
| Date of Event | 2014-03-05 |
| Device Manufacturer Date | 2013-02-26 |
| Date Added to Maude | 2016-09-22 |
| 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 | 0 |
| Brand Name | PHILIPS AVENT NIPLETTE |
| Generic Name | MANUALBREAST PUMP |
| Product Code | HGY |
| Date Received | 2014-03-10 |
| Model Number | SCF 152/02 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS ELECTRONICS UK LTD. |
| Manufacturer Address | GLEMSFORD UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-10 |