MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-11 for NEOCONNECT GRAVITYPRO PNM-S100NCV manufactured by Neomed, Inc..
| Report Number | 3006520777-2019-00007 |
| MDR Report Key | 8995174 |
| Date Received | 2019-09-11 |
| Date of Report | 2019-09-10 |
| Date of Event | 2019-07-22 |
| Report Date | 2019-07-29 |
| Date Reported to FDA | 2019-07-29 |
| Date Reported to Mfgr | 2019-08-06 |
| Date Mfgr Received | 2019-08-12 |
| Device Manufacturer Date | 2017-08-03 |
| Date Added to Maude | 2019-09-11 |
| 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 | 7705162225 |
| Manufacturer G1 | SYNECCO, CO., LTD. |
| Manufacturer Street | B801 RONGAN PLAZA, NO. 700 SOUTH TIANTONG ROAD |
| Manufacturer City | NINGBO, 315100 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 315100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOCONNECT GRAVITYPRO |
| Generic Name | ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS |
| Product Code | PNR |
| Date Received | 2019-09-11 |
| Returned To Mfg | 2019-09-03 |
| Model Number | PNM-S100NCV |
| Catalog Number | PNM-S100NCV |
| Lot Number | 20170720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-09-11 |