MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07,company representative, report with the FDA on 2013-02-28 for PHILIPS AVENT NIPLETTE SCF152/02 manufactured by Philips Electronics Uk Limited.
[17130574]
On (b)(6) 2013, consumer states her nipple is bleeding from using the niplette. After niplette was removed, one breast was red and swollen and the other was blistered and bleeding. Consumer states she rec'd the unit in the mail and used it for an hour or two. The niplette became full with cloudy liquid and blood. Consumer visited the doctor and was asked to have a mammogram and see a breast specialist.
Patient Sequence No: 1, Text Type: D, B5
[17358607]
On (b)(4) 2013, contacted the consumer. Consumer still has the niplette. Product was requested to be returned for evaluation. Consumer stated she is not pregnant and does not have any children. On (b)(6) 2013, consumer was contacted for add'l follow up. The nipple has scaring and a piece of tissue came off. Doctor advised that she might have difficulty breast feeding in the future. Consumer was given pain killers and was told to use a heating pad. Consumer was also given an antibiotic ointment. The consumer stated she is no longer having pain. The bleeding too proximately 1 1/2 to stop. The consumer has a condition called keloids. This is the first time the consumer has had this type of issue. This is the first use of the niplette. Consumer stated they are in a wheelchair, but would have the product returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[71007879]
On 11/11/2015 product was received and investigated. No product faults were observed that could cause the reported event. The niplettes are free of any sharp edges, and suction worked as expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8021997-2013-00001 |
| MDR Report Key | 2995259 |
| Report Source | 04,07,COMPANY REPRESENTATIVE, |
| Date Received | 2013-02-28 |
| Date of Report | 2013-02-21 |
| Date of Event | 2013-01-31 |
| Date Added to Maude | 2013-03-21 |
| 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 FERREIRA, SR. MGR |
| 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 NIPLETTE |
| Generic Name | NIPLETTE |
| Product Code | HGY |
| Date Received | 2013-02-28 |
| Model Number | SCF152/02 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2013-02-28 |