MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-14 for CATHETER PDLT-5519PC manufactured by Vas-cath Of Canada, Ltd..
[16397542]
Infected 19 cm soft cell catheter in right groin was removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005426 |
| MDR Report Key | 20246 |
| Date Received | 1995-03-14 |
| Date of Report | 1995-02-27 |
| Date of Event | 1995-02-15 |
| 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 | CATHETER |
| Generic Name | CATHETER |
| Product Code | LFK |
| Date Received | 1995-03-14 |
| Catalog Number | PDLT-5519PC |
| Lot Number | 505-1859 |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 20133 |
| Manufacturer | VAS-CATH OF CANADA, LTD. |
| Manufacturer Address | MISSISSAUGA ONTARIO CA L5A3V3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1995-03-14 |