MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-07-25 for POLYURETHANE NUTRISAFE 2 FEEDING TUBES 1364.042 manufactured by Vygon.
[114935115]
The sample has been kept and will be sent for investigation. The (b)(6) competent authority is aware of event. We have checked our history of complaints on this code these 2 last years (2016,2017, 2018). We received last year another complaint with a stomach wall perforation. This happened during a laparoscopy. The examination of the involved sample didn't shown any non conformity. The device was not the cause of that wall perforation. There is no complaint on this batch.
Patient Sequence No: 1, Text Type: N, H10
[114935116]
Neonate had a feeding tube in the stomach. The patient developed an acute abdomen. During the following surgery they found that the abdominal wall have rupture. The tube were placed under sterile conditions. No extended dwell time. Feeding of nutrition gradually breast milk. Patient currently stable. Neonate had a feeding tube in the stomach. The patient developed an acute abdomen. During the following surgery they found that the abdominal wall have rupture. The tube were placed under sterile conditions. No extended dwell time. Feeding of nutrition gradually breast milk. Patient currently stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245270-2018-00051 |
| MDR Report Key | 7717597 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-07-25 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-07-03 |
| Date Mfgr Received | 2018-07-09 |
| Date Added to Maude | 2018-07-25 |
| 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 | FREDA LACROIX |
| Manufacturer Street | 2750 MORRIS ROAD |
| Manufacturer City | LANSDALE PA 19446 |
| Manufacturer Country | US |
| Manufacturer Postal | 19446 |
| Manufacturer Phone | 8004735414 |
| Manufacturer G1 | VYGON |
| Manufacturer Street | 5 RUE ADELINE |
| Manufacturer City | ECOUEN, 95440 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 95440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYURETHANE NUTRISAFE 2 FEEDING TUBES |
| Generic Name | POLYURETHANE NUTRISAFE 2 FEEDING TUBES, |
| Product Code | FPD |
| Date Received | 2018-07-25 |
| Model Number | 1364.042 |
| Lot Number | 120418FF |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYGON |
| Manufacturer Address | 5 RUE ADELINE ECOUEN, 95440 FR 95440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-25 |