MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-14 for DIALYSIS GRAFT NI manufactured by Unknown.
[14138]
Infected dialysis graft of left thigh. Removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005437 |
| MDR Report Key | 20268 |
| Date Received | 1995-03-14 |
| Date of Report | 1995-02-27 |
| Date of Event | 1995-02-08 |
| Date Added to Maude | 1995-03-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIALYSIS GRAFT |
| Generic Name | DIALYSIS GRAFT |
| Product Code | FIQ |
| Date Received | 1995-03-14 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 20155 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1995-03-14 |