MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-05 for INTRAPERITONEAL PORT A CATH manufactured by Unk.
[85078246]
Enrolled in clinical trial for peritoneal carinomatosis. Trial directed therapy is iv folfiri every 14 days with intraperitoneal oxaliplatin every 14 days both administered on day 1. Subject is status post 3 cycles of treatment on protocol. He was seen by his local oncologist who recommended that he present to the emergency room to be admitted to the hospital for initiation of total parental nutrition (tpn) for anorexia (grade 3) and weight loss (grade 3). He is still currently admitted. Dose or amount: 105 mg, frequency: every 14 days, route: intraperitoneal; every 14 days intravenous drip. Dates of use: (b)(6) 2017. Diagnosis or reason for use: peritoneal carcinomatosis from appendiceal cancer. "is the product compounded: yes. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071964 |
| MDR Report Key | 6843484 |
| Date Received | 2017-09-05 |
| Date of Report | 2017-08-31 |
| Date of Event | 2017-08-28 |
| Date Added to Maude | 2017-09-05 |
| 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 | INTRAPERITONEAL PORT A CATH |
| Generic Name | INTRAPERITONEAL PORT A CATH |
| Product Code | LLD |
| Date Received | 2017-09-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-09-05 |