MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-04-30 for ENTERAL FEEDING TUBE manufactured by Neomed, Inc..
[143664971]
Neomed has contacted user facility for additional information regarding this event (b)(6)2019. Additional information has not yet been received.
Patient Sequence No: 1, Text Type: N, H10
[143664972]
A perforation was identified in a neonatal patient who had a neomed polyurethane feeding tube placed for gastric venting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006520777-2019-00006 |
| MDR Report Key | 8567084 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-30 |
| Date Mfgr Received | 2019-04-09 |
| Date Added to Maude | 2019-04-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MELINDA SMITH |
| Manufacturer Street | 100 LONDONDERRY COURT SUITE 112 |
| Manufacturer City | WOODSTOCK GA 30188 |
| Manufacturer Country | US |
| Manufacturer Postal | 30188 |
| Manufacturer Phone | 7704855188 |
| Manufacturer G1 | SYNECCO, CO., LTD. |
| Manufacturer Street | B801 RONGAN PLAZA NO. 700 SOUTH TIANTONG ROAD |
| Manufacturer City | NINGBO, YINZHOU DISTRICT 315100 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 315100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ENTERAL FEEDING TUBE |
| Product Code | FPD |
| Date Received | 2019-04-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOMED, INC. |
| Manufacturer Address | 100 LONDONDERRY CT. SUITE 112 WOODSTOCK GA 30188 US 30188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-30 |