FDA Adverse Event
Summary report: N
NEOMED
MDR report key: 2853267
·
Received November 23, 2012
Report
- Report Number
- 2853267
- Date Received
- November 23, 2012
- Date of Event
- November 1, 2012
- Report Date
- November 23, 2012
- Manufacturer
- NEOMED INCORPORATED
- Product Code
- FPD
- Report Source
- User Facility report
- Reporter Location
- WI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A FOUR WEEK OLD INFANT HAD A FEEDING TUBE REPLACED WITH A GASTRIC FEEDING TUBE (G-TUBE). AFTER PLACEMENT OF THE G-TUBE, INFANT HAD FREQUENT EMESIS, AND VOMITED A 4 CM PIECE OF THE END OF THE FEEDING TUBE. THE FEEDING TUBE FRAGMENT APPEARED TO HAVE BEEN CLEANLY CUT. IT IS UNKNOWN HOW THE TUBING WAS CUT, AS THE PLACEMENT OF THE G-TUBE DID NOT INCLUDE INCISION INTO STOMACH. THE INFANT'S EMESIS RESOLVED WITH NO FURTHER SIGNS OF DISTRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEOMED | TUBE, FEEDING | FPD | NEOMED INCORPORATED | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 * |