MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-11-29 for PERCUPUMP TOUCHSCREEN INJECTOR SYSTEM W/EDA 7805 manufactured by E-z-em, Inc..
[15258391]
Tech noticed swelling and shut off the injector with 80ml remaining. No alarm sounded. Tech estimated she used 10 ml for the test injection. Some contrast made it into the liver (very little). Procedure read as a non-contrast study. Maybe 20ml or a little more actually went into the vasculature. Extravasation estimated to be 30-40 ml. Pt treated with ice, heat, and elevation of the arm and was then released.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432460-2000-00039 |
| MDR Report Key | 307843 |
| Report Source | 05 |
| Date Received | 2000-11-29 |
| Date of Report | 2000-11-27 |
| Date of Event | 2000-10-26 |
| Date Facility Aware | 2000-10-26 |
| Report Date | 2000-11-27 |
| Date Reported to Mfgr | 2000-11-01 |
| Date Added to Maude | 2000-12-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PETER APRILE, R.PH. |
| Manufacturer Street | 717 MAIN STREET |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 8005444624 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERCUPUMP TOUCHSCREEN INJECTOR SYSTEM W/EDA |
| Generic Name | CT INJECTOR W/EXTRAVASATION ACCESSORY |
| Product Code | FIH |
| Date Received | 2000-11-29 |
| Model Number | NA |
| Catalog Number | 7805 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 297842 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | 113-117 MAGNOLIA AVE. WESTBURY NY 11590 US |
| Baseline Brand Name | PERCUPUMP TOUCHSCREEN INJECTOR W/EDA |
| Baseline Generic Name | CT INJECTOR SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | 7805 |
| Baseline ID | NA |
| Baseline Device Family | PERCUPUMP INJECTOR SYSTEM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K961845 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-11-29 |