MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-15 for PORT-A-CATH PERITONEAL PORT manufactured by Smiths Medical Asd, Inc..
[95179670]
Bgp diagnosed with appendiceal cancer with peritoneal carcinomatosis. Under clinical that treatment with folfiri + intraperitoneal oxaliplatin. Cycle 3 received on 12/04/2017. Subject presented to outside hospital with delirium, fever of 102f, and grade 3 infection of the intraperitoneal port. Pt currently admitted, being treated with iv antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074073 |
| MDR Report Key | 7124323 |
| Date Received | 2017-12-15 |
| Date of Report | 2017-12-14 |
| Date of Event | 2017-12-12 |
| Date Added to Maude | 2017-12-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | PORT-A-CATH PERITONEAL PORT |
| Generic Name | INTRAPERITONEAL PORTACATH |
| Product Code | LLD |
| Date Received | 2017-12-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-12-15 |