MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2001-05-29 for PERCUPUMP CT INJECTOR W/EDA 8805 manufactured by E-z-em, Inc..
[17483464]
Facility reported that 100cc of contrast was injected at a flow rate of 2. 0cc/sec. Upon viewing the first set of pictures, the technologist determined that there was no contrast in the pt's vascular system. There was no obvious extravasation or palpable mass upon checking the injection site. Pt had no complaints of pain or pressure. Dept nurse and radiologist were notified and both examined the pt. Radiologist determined that the contrast did extravasate beneath the pt's muscle. Pt was observed for approx one hour, cold compresses were applied and the pt was released. Radiologist would follow up with a phone call in 24 hours. Exam was completed (unenhanced scan) without reinjecting the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432460-2001-00010 |
| MDR Report Key | 335816 |
| Report Source | 05,06,07 |
| Date Received | 2001-05-29 |
| Date of Report | 2001-04-26 |
| Date of Event | 2001-04-25 |
| Date Facility Aware | 2001-04-25 |
| Report Date | 2001-04-26 |
| Date Reported to Mfgr | 2001-04-26 |
| Date Mfgr Received | 2001-04-26 |
| Device Manufacturer Date | 2000-01-01 |
| Date Added to Maude | 2001-06-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH MERITZ, VP |
| 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 CT INJECTOR W/EDA |
| Generic Name | CT INJECTOR WITH EXTRAVASATION ACCESSORY |
| Product Code | FIH |
| Date Received | 2001-05-29 |
| Model Number | NA |
| Catalog Number | 8805 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 15 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 325159 |
| 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 | 8805 |
| 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 | 20 | 1. Other | 2001-05-29 |