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 2005-02-18 for PERCUPUMP TOUCHSCREEN INJECTOR W/ EDA 8805 manufactured by E-z-em, Inc..
[22083762]
During an injection of intravenous contrast at a rate of 1. 7 cc/sec the patient's iv infiltrated (right antecubital site) and approximately 90 cc's of omnipaque 300 extravasated into the surrounding soft tissues of the upper right arm. Extravasation seen on the ct scan.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411512-2005-00004 |
| MDR Report Key | 589808 |
| Report Source | 05,06,07 |
| Date Received | 2005-02-18 |
| Date of Report | 2005-01-19 |
| Date of Event | 2004-12-01 |
| Date Facility Aware | 2004-12-01 |
| Report Date | 2005-01-19 |
| Date Reported to Mfgr | 2005-01-19 |
| Date Mfgr Received | 2005-01-19 |
| Device Manufacturer Date | 2001-03-01 |
| Date Added to Maude | 2005-04-12 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | GINA VOGELSBERG COMPLAINT MGR |
| Manufacturer Street | 717 MAIN STREET |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 5163338230 |
| Manufacturer G1 | E-Z-EM,INC |
| Manufacturer Street | 717 MAIN ST. |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11590 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERCUPUMP TOUCHSCREEN INJECTOR W/ EDA |
| Generic Name | CT INJECTOR W/ EXTRAVASATION ACCESSORY |
| Product Code | FIH |
| Date Received | 2005-02-18 |
| Model Number | NA |
| Catalog Number | 8805 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 46 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 579658 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | * WESTBURY NY * 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 | 0 | 1. Other | 2005-02-18 |