MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-27 for NEOMED manufactured by Neomed, Inc..
[140829712]
Gastric perforation identified after the baby showed signs and symptoms of abdominal distention. Periodogram revealed intra-abdominal air. Pediatric surgery consulted. Gastric perforation identified and corrected in surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8479497 |
| MDR Report Key | 8479497 |
| Date Received | 2019-03-27 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-03-16 |
| Date Facility Aware | 2019-03-16 |
| Report Date | 2019-03-27 |
| Date Reported to FDA | 2019-03-27 |
| Date Reported to Mfgr | 2019-03-27 |
| Date Added to Maude | 2019-04-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOMED |
| Generic Name | ENTERAL FEEDING TUBE |
| Product Code | FPD |
| Date Received | 2019-03-27 |
| Lot Number | 20180825 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOMED, INC. |
| Manufacturer Address | WOODSTOCK GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-27 |