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 2019-04-15 for NEOMED ENTERAL FEEDING TUBE PFTM8.0P-EO manufactured by Neomed, Inc.
[141951328]
This report is in response to medwatch user facility report # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141951329]
Gastric perforation was identified in a sextuplet nicu patient (patient identifier: (b)(6)) after signs and symptoms of abdominal distention. Gastric perforation was identified and corrected in surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006520777-2019-00003 |
| MDR Report Key | 8514521 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-15 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-03-16 |
| Date Mfgr Received | 2019-03-19 |
| Device Manufacturer Date | 2018-08-25 |
| Date Added to Maude | 2019-04-15 |
| 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 |
| Brand Name | NEOMED ENTERAL FEEDING TUBE |
| Generic Name | TUBE, FEEDING |
| Product Code | FPD |
| Date Received | 2019-04-15 |
| Model Number | PFTM8.0P-EO |
| Catalog Number | PFTM8.0P-EO |
| Lot Number | 20180825 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOMED, INC |
| Manufacturer Address | 100 LONDONDERRY COURT SUITE 112 WOODSTOCK GA 30188 US 30188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-15 |