MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-19 for UNKNOWN manufactured by Unknown.
[19708485]
Pt. Diagnosis: lymphoma with neonfunctioning port that was placed at charity another hospital in june. The mediport was removed but the catheter was not attached to it and was not evident on flouro or in the tunnel. A new double lumen placed without difficulty (per the operative note). Catheter did show up on cxr 8/1/94 but not evident on 8/5/94 films. Pt. Expired 8/15/94 with aggressive lymphoma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 25789 |
| MDR Report Key | 25789 |
| Date Received | 1995-01-19 |
| Date of Report | 1994-09-22 |
| Date of Event | 1994-08-10 |
| Date Added to Maude | 1995-09-20 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | MEDIPORT |
| Product Code | FGH |
| Date Received | 1995-01-19 |
| Model Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 26387 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-01-19 |