MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-24 for PERMACATH-GORTEX PATCH UNK manufactured by Quinton.
[88036]
Removal of infected permacath (femoral-r).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 142440 |
| MDR Report Key | 142440 |
| Date Received | 1997-12-24 |
| Date of Report | 1997-09-12 |
| Date of Event | 1997-08-01 |
| Date Facility Aware | 1997-09-11 |
| Report Date | 1997-09-12 |
| Date Reported to Mfgr | 1997-09-12 |
| Date Added to Maude | 1998-01-13 |
| 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 | PERMACATH-GORTEX PATCH |
| Generic Name | CATHETER |
| Product Code | LFK |
| Date Received | 1997-12-24 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 8012-079 |
| ID Number | 5.0 CM X 7.5 CM |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 20 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 134861 |
| Manufacturer | QUINTON |
| Manufacturer Address | 2121 TERRY AVENUE SEATTLE WA 981212791 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1997-12-24 |